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H.R. 4433 (ih) - To protect the public health by providing the Food and Drug Administration with certain authority to re

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H.R. 4433 (ih) - To protect the public health by providing the Food and Drug Administration with certain authority to re Powered By Docstoc
					I

108TH CONGRESS 2D SESSION

H. R. 4433

To protect the public health by providing the Food and Drug Administration with certain authority to regulate tobacco products.

IN THE HOUSE OF REPRESENTATIVES
MAY 20, 2004 Mr. TOM DAVIS of Virginia (for himself, Mr. WAXMAN, Mr. PLATTS, and Mr. MEEHAN) introduced the following bill; which was referred to the Committee on Energy and Commerce

A BILL
To protect the public health by providing the Food and Drug Administration with certain authority to regulate tobacco products. 1 Be it enacted by the Senate and House of Representa-

2 tives of the United States of America in Congress assembled, 3 4
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) SHORT TITLE.—This Act may be cited as the

5 ‘‘Family Smoking Prevention and Tobacco Control Act’’. 6 (b) TABLE
OF

CONTENTS.—The table of contents of

7 this Act is as follows:
Sec. Sec. Sec. Sec. 1. 2. 3. 4. Short title; table of contents. Findings. Purpose. Scope and effect.

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Sec. 5. Severability. TITLE I—AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION Sec. 101. Amendment of Federal food, drug, and cosmetic act. Sec. 102. Construction of current regulations. Sec. 103. Conforming and other amendments to general provisions. TITLE II—TOBACCO PRODUCT WARNINGS; CONSTITUENT AND SMOKE CONSTITUENT DISCLOSURE Cigarette label and advertising warnings. Authority to revise cigarette warning label Statements. State regulation of cigarette advertising and promotion. Smokeless tobacco labels and advertising warnings. Authority to revise smokeless tobacco product warning label Statements. Sec. 206. Tar, nicotine, and other smoke constituent disclosure to the public. TITLE III—PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS Sec. 301. Labeling, record keeping, records inspection. Sec. 302. Study and report. Sec. Sec. Sec. Sec. Sec. 201. 202. 203. 204. 205.

1 2 3 4 5 6 7 8 9 10 11 12 13 14

SEC. 2. FINDINGS.

The Congress finds the following: (1) The use of tobacco products by the Nation’s children is a pediatric disease of considerable proportions that results in new generations of tobaccodependent children and adults. (2) A consensus exists within the scientific and medical communities that tobacco products are inherently dangerous and cause cancer, heart disease, and other serious adverse health effects. (3) Nicotine is an addictive drug. (4) Virtually all new users of tobacco products are under the minimum legal age to purchase such products.
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3 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 (5) Tobacco advertising and marketing contribute significantly to the use of nicotine-containing tobacco products by adolescents. (6) Because past efforts to restrict advertising and marketing of tobacco products have failed adequately to curb tobacco use by adolescents, comprehensive restrictions on the sale, promotion, and distribution of such products are needed. (7) Federal and State governments have lacked the legal and regulatory authority and resources they need to address comprehensively the public health and societal problems caused by the use of tobacco products. (8) Federal and State public health officials, the public health community, and the public at large recognize that the tobacco industry should be subject to ongoing oversight. (9) Under Article I, Section 8 of the Constitution, the Congress is vested with the responsibility for regulating interstate commerce and commerce with Indian tribes. (10) The sale, distribution, marketing, advertising, and use of tobacco products are activities in and substantially affecting interstate commerce because they are sold, marketed, advertised, and dis-

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4 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 tributed in interstate commerce on a nationwide basis, and have a substantial effect on the Nation’s economy. (11) The sale, distribution, marketing, advertising, and use of such products substantially affect interstate commerce through the health care and other costs attributable to the use of tobacco products. (12) It is in the public interest for Congress to enact legislation that provides the Food and Drug Administration with the authority to regulate tobacco products and the advertising and promotion of such products. The benefits to the American people from enacting such legislation would be significant in human and economic terms. (13) Tobacco use is the foremost preventable cause of premature death in America. It causes over 400,000 deaths in the United States each year and approximately 8,600,000 Americans have chronic illnesses related to smoking. (14) Reducing the use of tobacco by minors by 50 percent would prevent well over 6,500,000 of today’s children from becoming regular, daily smokers, saving over 2,000,000 of them from premature death due to tobacco induced disease. Such a reduc-

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5 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 tion in youth smoking would also result in approximately $75,000,000,000 in savings attributable to reduced health care costs. (15) Advertising, marketing, and promotion of tobacco products have been especially directed to attract young persons to use tobacco products and these efforts have resulted in increased use of such products by youth. Past efforts to oversee these activities have not been successful in adequately preventing such increased use. (16) In 2001, the tobacco industry spent more than $11,000,000,000 to attract new users, retain current users, increase current consumption, and generate favorable long-term attitudes toward smoking and tobacco use. (17) Tobacco product advertising often

misleadingly portrays the use of tobacco as socially acceptable and healthful to minors. (18) Tobacco product advertising is regularly seen by persons under the age of 18, and persons under the age of 18 are regularly exposed to tobacco product promotional efforts. (19) Through advertisements during and sponsorship of sporting events, tobacco has become strongly associated with sports and has become por-

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6 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 trayed as an integral part of sports and the healthy lifestyle associated with rigorous sporting activity. (20) Children are exposed to substantial and unavoidable tobacco advertising that leads to favorable beliefs about tobacco use, plays a role in leading young people to overestimate the prevalence of tobacco use, and increases the number of young people who begin to use tobacco. (21) The use of tobacco products in motion pictures and other mass media glamorizes its use for young people and encourages them to use tobacco products. (22) Tobacco advertising expands the size of the tobacco market by increasing consumption of tobacco products including tobacco use by young people. (23) Children are more influenced by tobacco advertising than adults, they smoke the most advertised brands. (24) Tobacco company documents indicate that young people are an important and often crucial segment of the tobacco market. Children, who tend to be more price-sensitive than adults, are influenced by advertising and promotion practices that result in drastically reduced cigarette prices.

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7 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 (25) Comprehensive advertising restrictions will have a positive effect on the smoking rates of young people. (26) Restrictions on advertising are necessary to prevent unrestricted tobacco advertising from undermining legislation prohibiting access to young people and providing for education about tobacco use. (27) International experience shows that advertising regulations that are stringent and comprehensive have a greater impact on overall tobacco use and young people’s use than weaker or less comprehensive ones. (28) Text only requirements, although not as stringent as a ban, will help reduce underage use of tobacco products while preserving the informational function of advertising. (29) It is in the public interest for Congress to adopt legislation to address the public health crisis created by actions of the tobacco industry. (30) The final regulations promulgated by the Secretary of Health and Human Services in the August 28, 1996, issue of the Federal Register (61 Fed. Reg. 44615–44618) for inclusion as part 897 of title 21, Code of Federal Regulations, are con-

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8 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 sistent with the First Amendment to the United States Constitution and with the standards set forth in the amendments made by this Act for the regulation of tobacco products by the Food and Drug Administration and the restriction on the sale and distribution, including access to and the advertising and promotion of, tobacco products contained in such regulations are substantially related to accomplishing the public health goals of this Act. (31) The regulations described in paragraph (30) will directly and materially advance the Federal Government’s substantial interest in reducing the number of children and adolescents who use cigarettes and smokeless tobacco and in preventing the life-threatening health consequences associated with tobacco use. An overwhelming majority of Americans who use tobacco products begin using such products while they are minors and become addicted to the nicotine in those products before reaching the age of 18. Tobacco advertising and promotion plays a crucial role in the decision of these minors to begin using tobacco products. Less restrictive and less comprehensive approaches have not and will not be effective in reducing the problems addressed by such regulations. The reasonable restrictions on the ad-

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9 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 vertising and promotion of tobacco products contained in such regulations will lead to a significant decrease in the number of minors using and becoming addicted to those products. (32) The regulations described in paragraph (30) impose no more extensive restrictions on communication by tobacco manufacturers and sellers than are necessary to reduce the number of children and adolescents who use cigarettes and smokeless tobacco and to prevent the life-threatening health consequences associated with tobacco use. Such regulations are narrowly tailored to restrict those advertising and promotional practices which are most likely to be seen or heard by youth and most likely to entice them into tobacco use, while affording tobacco manufacturers and sellers ample opportunity to convey information about their products to adult consumers. (33) Tobacco dependence is a chronic disease, one that typically requires repeated interventions to achieve long-term or permanent abstinence. (34) Because the only known safe alternative to smoking is cessation, interventions should target all smokers to help them quit completely.

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10 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 (35) Tobacco products have been used to facilitate and finance criminal activities both domestically and internationally. Illicit trade of tobacco products has been linked to organized crime and terrorist groups. (36) It is essential that the Food and Drug Administration review products sold or distributed for use to reduce risks or exposures associated with tobacco products and that it be empowered to review any advertising and labeling for such products. It is also essential that manufacturers, prior to marketing such products, be required to demonstrate that such products will meet a series of rigorous criteria, and will benefit the health of the population as a whole, taking into account both users of tobacco products and persons who do not currently use tobacco products. (37) Unless tobacco products that purport to reduce the risks to the public of tobacco use actually reduce such risks, those products can cause substantial harm to the public health to the extent that the individuals, who would otherwise not consume tobacco products or would consume such products less, use tobacco products purporting to reduce risk. Those who use products sold or distributed as modi-

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11 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 fied risk products that do not in fact reduce risk, rather than quitting or reducing their use of tobacco products, have a substantially increased likelihood of suffering disability and premature death. The costs to society of the widespread use of products sold or distributed as modified risk products that do not in fact reduce risk or that increase risk include thousands of unnecessary deaths and injuries and huge costs to our health care system. (38) As the National Cancer Institute has found, many smokers mistakenly believe that ‘‘low tar’’ and ‘‘light’’ cigarettes cause fewer health problems than other cigarettes. As the National Cancer Institute has also found, mistaken beliefs about the health consequences of smoking ‘‘low tar’’ and ‘‘light’’ cigarettes can reduce the motivation to quit smoking entirely and thereby lead to disease and death. (39) Recent studies have demonstrated that there has been no reduction in risk on a populationwide basis from ‘‘low tar’’ and ‘‘light’’ cigarettes and such products may actually increase the risk of tobacco use. (40) The dangers of products sold or distributed as modified risk tobacco products that do not

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12 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 in fact reduce risk are so high that there is a compelling governmental interest in insuring that statements about modified risk tobacco products are complete, accurate, and relate to the overall disease risk of the product. (41) As the Federal Trade Commission has found, consumers have misinterpreted advertisements in which one product is claimed to be less harmful than a comparable product, even in the presence of disclosures and advisories intended to provide clarification. (42) Permitting manufacturers to make unsubstantiated statements concerning modified risk tobacco products, whether express or implied, even if accompanied by disclaimers would be detrimental to the public health. (43) The only way to effectively protect the public health from the dangers of unsubstantiated modified risk tobacco products is to empower the Food and Drug Administration to require that products that tobacco manufacturers sold or distributed for risk reduction be approved in advance of marketing, and to require that the evidence relied on to support approval of these products is rigorous.

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SEC. 3. PURPOSE.

The purposes of this Act are— (1) to provide authority to the Food and Drug Administration to regulate tobacco products under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), by recognizing it as the primary Federal regulatory authority with respect to the manufacture, marketing, and distribution of tobacco products; (2) to ensure that the Food and Drug Administration has the authority to address issues of particular concern to public health officials, especially the use of tobacco by young people and dependence on tobacco; (3) to authorize the Food and Drug Administration to set national standards controlling the manufacture of tobacco products and the identity, public disclosure, and amount of ingredients used in such products; (4) to provide new and flexible enforcement authority to ensure that there is effective oversight of the tobacco industry’s efforts to develop, introduce, and promote less harmful tobacco products; (5) to vest the Food and Drug Administration with the authority to regulate the levels of tar, nico-

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14 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 tine, and other harmful components of tobacco products; (6) in order to ensure that consumers are better informed, to require tobacco product manufacturers to disclose research which has not previously been made available, as well as research generated in the future, relating to the health and dependency effects or safety of tobacco products; (7) to continue to permit the sale of tobacco products to adults in conjunction with measures to ensure that they are not sold or accessible to underage purchasers; (8) to impose appropriate regulatory controls on the tobacco industry; (9) to promote cessation to reduce disease risk and the social costs associated with tobacco related diseases; and (10) to strengthen legislation against illicit trade in tobacco products.
SEC. 4. SCOPE AND EFFECT.

(a) INTENDED EFFECT.—Nothing in this Act (or an

22 amendment made by this Act) shall be construed to— 23 24 25 (1) establish a precedent with regard to any other industry, situation, circumstance, or legal action; or

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15 1 2 3 4 (2) affect any action pending in Federal, State, or Tribal court, or any agreement, consent decree, or contract of any kind. (b) AGRICULTURAL ACTIVITIES.—The provisions of

5 this Act (or an amendment made by this Act) which au6 thorize the Secretary to take certain actions with regard 7 to tobacco and tobacco products shall not be construed to 8 affect any authority of the Secretary of Agriculture under 9 existing law regarding the growing, cultivation, or curing 10 of raw tobacco. 11 12
SEC. 5. SEVERABILITY.

If any provision of this Act, the amendments made

13 by this Act, or the application of any provision of this Act 14 to any person or circumstance is held to be invalid, the 15 remainder of this Act, the amendments made by this Act, 16 and the application of the provisions of this Act to any 17 other person or circumstance shall not be affected and 18 shall continue to be enforced to the fullest extent possible. 19 20 21 22 23 24

TITLE I—AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION
SEC. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC ACT.

(a) DEFINITION

OF

TOBACCO PRODUCTS.—Section

25 201 of the Federal Food, Drug, and Cosmetic Act (21

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16 1 U.S.C. 321) is amended by adding at the end the fol2 lowing: 3 ‘‘(nn)(1) The term ‘tobacco product’ means any prod-

4 uct made or derived from tobacco that is intended for 5 human consumption, including any component, part, or 6 accessory of a tobacco product (except for raw materials 7 other than tobacco used in manufacturing a component, 8 part, or accessory of a tobacco product). 9 10 11 12 13 14 15 16 17 ‘‘(2) The term ‘tobacco product’ does not mean— ‘‘(A) a product in the form of conventional food (including water and chewing gum), a product represented for use as or for use in a conventional food, or a product that is intended for ingestion in capsule, tablet, softgel, or liquid form; or ‘‘(B) an article that is approved or is regulated as a drug by the Food and Drug Administration. ‘‘(3) The products described in paragraph (2)(A)

18 shall be subject to chapter IV or chapter V of this Act 19 and the articles described in paragraph (2)(B) shall be 20 subject to chapter V of this Act. 21 ‘‘(4) A tobacco product may not be marketed in com-

22 bination with any other article or product regulated under 23 this Act (including a drug, biologic, food, cosmetics, med24 ical device, or a dietary supplement).’’.

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17 1 (b) FDA AUTHORITY OVER TOBACCO PRODUCTS.—

2 The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 3 301 et seq.) is amended— 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 (1) by redesignating chapter IX as chapter X; (2) by redesignating sections 901 through 907 as sections 1001 through 1007; and (3) by inserting after section 803 the following:

‘‘CHAPTER IX—TOBACCO PRODUCTS
‘‘SEC. 900. DEFINITIONS.

‘‘In this chapter: ‘‘(1) ADDITIVE.—The term ‘additive’ means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic of any tobacco product (including any substances intended for use as a flavoring, coloring or in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding), except that such term does not include tobacco or a pesticide chemical residue in or on raw tobacco or a pesticide chemical. ‘‘(2) BRAND.—The term ‘brand’ means a variety of tobacco product distinguished by the tobacco used, tar content, nicotine content, flavoring used,

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18 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 size, filtration, or packaging, logo, registered trademark or brand name, identifiable pattern of colors, or any combination of such attributes. ‘‘(3) CIGARETTE.—The term ‘cigarette’ has the meaning given that term by section 3(1) of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1332(1)), but also includes tobacco, in any form, that is functional in the product, which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette or as roll-your-own tobacco. ‘‘(4) CIGARETTE
TOBACCO.—The

term ‘ciga-

rette tobacco’ means any product that consists of loose tobacco that is intended for use by consumers in a cigarette. Unless otherwise stated, the requirements for cigarettes shall also apply to cigarette tobacco. ‘‘(5) COMMERCE.—The term ‘commerce’ has the meaning given that term by section 3(2) of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1332(2)). ‘‘(6) COUNTERFEIT
TOBACCO PRODUCT.—The

term ‘counterfeit tobacco product’ means a tobacco product (or the container or labeling of such a prod-

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19 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 uct) that, without authorization, bears the trademark, trade name, or other identifying mark, imprint or device, or any likeness thereof, of a tobacco product listed in a registration under section 905(i)(1). ‘‘(7) DISTRIBUTOR.—The term ‘distributor’ as regards a tobacco product means any person who furthers the distribution of a tobacco product, whether domestic or imported, at any point from the original place of manufacture to the person who sells or distributes the product to individuals for personal consumption. Common carriers are not considered distributors for purposes of this chapter. ‘‘(8) ILLICIT
TRADE.—The

term ‘illicit trade’

means any practice or conduct prohibited by law which relates to production, shipment, receipt, possession, distribution, sale, or purchase of tobacco products including any practice or conduct intended to facilitate such activity. ‘‘(9) INDIAN
TRIBE.—The

term ‘Indian tribe’

has the meaning given such term in section 4(e) of the Indian Self Determination and Education Assistance Act (25 U.S.C. 450b(e)). ‘‘(10) LITTLE
CIGAR.—The

term ‘little cigar’

has the meaning given that term by section 3(7) of

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20 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 the the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1332(7)). ‘‘(11) NICOTINE.—The term ‘nicotine’ means chemical substance named 3-(1-Methyl-2-

pyrrolidinyl) pyridine or C[10]H[14]N[2], including any salt or complex of nicotine. ‘‘(12) PACKAGE.—The term ‘package’ means a pack, box, carton, or container of any kind or, if no other container, any wrapping (including cellophane), in which a tobacco product is offered for sale, sold, or otherwise distributed to consumers. ‘‘(13) RETAILER.—The term ‘retailer’ means any person who sells tobacco products to individuals for personal consumption, or who operates a facility where self-service displays of tobacco products are permitted. ‘‘(14) ROLL-YOUR-OWN
TOBACCO.—The

term

‘roll-your-own tobacco’ means any tobacco which, because of its appearance, type, packaging, or labeling, is suitable for use and likely to be offered to, or purchased by, consumers as tobacco for making cigarettes. ‘‘(15) SMOKE
CONSTITUENT.—The

term ‘smoke

constituent’ means any chemical or chemical compound in mainstream or sidestream tobacco smoke

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21 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 that either transfers from any component of the cigarette to the smoke or that is formed by the combustion or heating of tobacco, additives, or other component of the tobacco product. ‘‘(16) SMOKELESS
TOBACCO.—The

term

‘smokeless tobacco’ means any tobacco product that consists of cut, ground, powdered, or leaf tobacco and that is intended to be placed in the oral or nasal cavity. ‘‘(17) STATE.—The term ‘State’ means any State of the United States and, for purposes of this chapter, includes the District of Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin Islands, American Samoa, Wake Island, Midway Islands, Kingman Reef, Johnston Atoll, the Northern Mariana Islands, and any other trust territory or possession of the United States. ‘‘(18) TOBACCO
PRODUCT MANUFACTURER.—

Term ‘tobacco product manufacturer’ means any person, including any repacker or relabeler, who— ‘‘(A) manufactures, fabricates, assembles, processes, or labels a tobacco product; or ‘‘(B) imports a finished cigarette or smokeless tobacco product for sale or distribution in the United States.

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22 1 2 3 4 5 6 7 8 9 10 ‘‘(19) UNITED
STATES.—The

term ‘United

States’ means the 50 States of the United States of America and the District of Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin Islands, American Samoa, Wake Island, Midway Islands, Kingman Reef, Johnston Atoll, the Northern Mariana Islands, and any other trust territory or possession of the United States.
‘‘SEC. 901. FDA AUTHORITY OVER TOBACCO PRODUCTS.

‘‘(a) IN GENERAL.—Tobacco products shall be regu-

11 lated by the Secretary under this chapter and shall not 12 be subject to the provisions of chapter V, unless— 13 14 15 16 17 18 19 20 21 ‘‘(1) such products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease (within the meaning of section

201(g)(1)(B) or section 201(h)(2)); or ‘‘(2) a claim is made for such products under section 201(g)(1)(C) or 201(h)(3); other than modified risk tobacco products approved in accordance with section 911. ‘‘(b) APPLICABILITY.—This chapter shall apply to all

22 tobacco products subject to the regulations referred to in 23 section 102 of the Family Smoking Prevention and To24 bacco Control Act, and to any other tobacco products that

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23 1 the Secretary by regulation deems to be subject to this 2 chapter. 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 ‘‘(c) SCOPE.— ‘‘(1) IN
GENERAL.—Nothing

in this chapter, or

any policy issued or regulation promulgated thereunder, or the Family Smoking Prevention and Tobacco Control Act, shall be construed to affect the Secretary’s authority over, or the regulation of, products under this Act that are not tobacco products under chapter V or any other chapter. ‘‘(2) LIMITATION ‘‘(A) IN
OF AUTHORITY.—

GENERAL.—The

provisions of this

chapter shall not apply to tobacco leaf that is not in the possession of a manufacturer of tobacco products, or to the producers of tobacco leaf, including tobacco growers, tobacco warehouses, and tobacco grower cooperatives, nor shall any employee of the Food and Drug Administration have any authority to enter onto a farm owned by a producer of tobacco leaf without the written consent of such producer. ‘‘(B) EXCEPTION.—Notwithstanding any other provision of this subparagraph, if a producer of tobacco leaf is also a tobacco product manufacturer or controlled by a tobacco prod-

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24 1 2 3 4 5 6 7 8 9 10 11 12 13 if— 14 15 16 17 18 19 20 21 22 23 24 25 ‘‘(1) it consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise contaminated by any added poisonous or added deleterious substance that may render the product injurious to health; ‘‘(2) it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; ‘‘(3) its package is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; uct manufacturer, the producer shall be subject to this chapter in the producer’s capacity as a manufacturer. ‘‘(C) RULE
OF CONSTRUCTION.—Nothing

in this chapter shall be construed to grant the Secretary authority to promulgate regulations on any matter that involves the production of tobacco leaf or a producer thereof, other than activities by a manufacturer affecting production.
‘‘SEC. 902. ADULTERATED TOBACCO PRODUCTS.

‘‘A tobacco product shall be deemed to be adulterated

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25 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 ‘‘(4) it is, or purports to be or is represented as, a tobacco product which is subject to a tobacco product standard established under section 907 unless such tobacco product is in all respects in conformity with such standard; ‘‘(5)(A) it is required by section 910(a) to have premarket approval and does not have an approved application in effect; or ‘‘(B) it is in violation of the order approving such an application; ‘‘(6) the methods used in, or the facilities or controls used for, its manufacture, packing or storage are not in conformity with applicable requirements under section 906(e)(1) or an applicable condition prescribed by an order under section

906(e)(2); and ‘‘(7) it is in violation of section 911.
‘‘SEC. 903. MISBRANDED TOBACCO PRODUCTS.

‘‘(a) IN GENERAL.—A tobacco product shall be

20 deemed to be misbranded— 21 22 23 24 ‘‘(1) if its labeling is false or misleading in any particular; ‘‘(2) if in package form unless it bears a label containing—

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26 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 ‘‘(A) the name and place of business of the tobacco product manufacturer, packer, or distributor; ‘‘(B) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; ‘‘(C) an accurate statement of the percentage of the tobacco used in the product that is domestically grown tobacco and the percentage that is foreign grown tobacco; and ‘‘(D) the statement required under section 921(a), except that under subparagraph (B) reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary; ‘‘(3) if any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements or designs in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;

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27 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 ‘‘(4) if it has an established name, unless its label bears, to the exclusion of any other nonproprietary name, its established name prominently printed in type as required by the Secretary by regulation; ‘‘(5) if the Secretary has issued regulations requiring that its labeling bear adequate directions for use, or adequate warnings against use by children, that are necessary for the protection of users unless its labeling conforms in all respects to such regulations; ‘‘(6) if it was manufactured, prepared, propagated, compounded, or processed in any State in an establishment not duly registered under section 905(b), 905(c), 905(d), or 905(h), if it was not included in a list required by section 905(i), if a notice or other information respecting it was not provided as required by such section or section 905(j), or if it does not bear such symbols from the uniform system for identification of tobacco products prescribed under section 905(e) as the Secretary by regulation requires; ‘‘(7) if, in the case of any tobacco product distributed or offered for sale in any State—

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28 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 ‘‘(A) its advertising is false or misleading in any particular; or ‘‘(B) it is sold or distributed in violation of regulations prescribed under section 906(d); ‘‘(8) unless, in the case of any tobacco product distributed or offered for sale in any State, the manufacturer, packer, or distributor thereof includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to that tobacco product— ‘‘(A) a true statement of the tobacco product’s established name as described in paragraph (4), printed prominently; and ‘‘(B) a brief statement of— ‘‘(i) the uses of the tobacco product and relevant warnings, precautions, side effects, and contraindications; and ‘‘(ii) in the case of specific tobacco products made subject to a finding by the Secretary after notice and opportunity for comment that such action is appropriate to protect the public health, a full description of the components of such tobacco product or the formula showing quantitatively each

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29 1 2 3 4 5 6 7 8 9 10 11 12 13 14 ingredient of such tobacco product to the extent required in regulations which shall be issued by the Secretary after an opportunity for a hearing; ‘‘(9) if it is a tobacco product subject to a tobacco product standard established under section 907, unless it bears such labeling as may be prescribed in such tobacco product standard; or ‘‘(10) if there was a failure or refusal— ‘‘(A) to comply with any requirement prescribed under section 904 or 908; or ‘‘(B) to furnish any material or information required under section 909. ‘‘(b) PRIOR APPROVAL
OF

LABEL STATEMENTS.—

15 The Secretary may, by regulation, require prior approval 16 of statements made on the label of a tobacco product. No 17 regulation issued under this subsection may require prior 18 approval by the Secretary of the content of any advertise19 ment, except for modified risk tobacco products as pro20 vided in section 911. No advertisement of a tobacco prod21 uct published after the date of enactment of the Family 22 Smoking Prevention and Tobacco Control Act shall, with 23 respect to the language of label statements as prescribed 24 under section 4 of the Cigarette Labeling and Advertising 25 Act and section 3 of the Comprehensive Smokeless To-

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30 1 bacco Health Education Act of 1986 or the regulations 2 issued under such sections, be subject to the provisions 3 of sections 12 through 15 of the Federal Trade Commis4 sion Act (15 U.S.C. 52 through 55). 5 6 7
‘‘SEC. 904. SUBMISSION OF HEALTH INFORMATION TO THE SECRETARY.

‘‘(a) REQUIREMENT.—Not later than 6 months after

8 the date of enactment of the Family Smoking Prevention 9 and Tobacco Control Act, each tobacco product manufac10 turer or importer, or agents thereof, shall submit to the 11 Secretary the following information: 12 13 14 15 16 17 18 19 20 21 22 23 24 25 ‘‘(1) A listing of all ingredients, including tobacco, substances, compounds, and additives that are, as of such date, added by the manufacturer to the tobacco, paper, filter, or other part of each tobacco product by brand and by quantity in each brand and subbrand. ‘‘(2) A description of the content, delivery, and form of nicotine in each tobacco product measured in milligrams of nicotine in accordance with regulations promulgated by the Secretary in accordance with section 4(a)(4) of the Federal Cigarette Labeling and Advertising Act. ‘‘(3) A listing of all constituents, including smoke constituents as applicable, identified by the

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31 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 Secretary as harmful or potentially harmful to health in each tobacco product, and as applicable in the smoke of each tobacco product, by brand and by quantity in each brand and subbrand. Effective beginning 2 years after the date of enactment of this chapter, the manufacturer, importer, or agent shall comply with regulations promulgated under section 916 in reporting information under this paragraph, where applicable. ‘‘(4) All documents developed after the date of enactment of the Family Smoking Prevention and Tobacco Control Act that relate to health, toxicological, behavioral, or physiologic effects of current or future tobacco products, their constituents (including smoke constituents), ingredients, components, and additives. ‘‘(b) DATA SUBMISSION.—At the request of the Sec-

18 retary, each tobacco product manufacturer or importer of 19 tobacco products, or agents thereof, shall submit the fol20 lowing: 21 22 23 24 25 ‘‘(1) Any or all documents (including underlying scientific information) relating to research activities, and research findings, conducted, supported, or possessed by the manufacturer (or agents thereof) on the health, toxicological, behavioral, or physio-

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32 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 logic effects of tobacco products and their constituents (including smoke constituents), ingredients, components, and additives. ‘‘(2) Any or all documents (including underlying scientific information) relating to research activities, and research findings, conducted, supported, or possessed by the manufacturer (or agents thereof) that relate to the issue of whether a reduction in risk to health from tobacco products can occur upon the employment of technology available or known to the manufacturer. ‘‘(3) Any or all documents (including underlying scientific or financial information) relating to marketing research involving the use of tobacco products or marketing practices and the effectiveness of such practices used by tobacco manufacturers and distributors.

18 An importer of a tobacco product not manufactured in the 19 United States shall supply the information required of a 20 tobacco product manufacturer under this subsection. 21 22 23 24 25 ‘‘(c) TIME FOR SUBMISSION.— ‘‘(1) IN
GENERAL.—At

least 90 days prior to

the delivery for introduction into interstate commerce of a tobacco product not on the market on the date of enactment of the Family Smoking Preven-

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33 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 tion and Tobacco Control Act, the manufacturer of such product shall provide the information required under subsection (a). ‘‘(2) DISCLOSURE
OF ADDITIVE.—If

at any

time a tobacco product manufacturer adds to its tobacco products a new tobacco additive or increases the quantity of an existing tobacco additive, the manufacturer shall, except as provided in paragraph (3), at least 90 days prior to such action so advise the Secretary in writing. ‘‘(3) DISCLOSURE
OF OTHER ACTIONS.—If

at

any time a tobacco product manufacturer eliminates or decreases an existing additive, or adds or increases an additive that has by regulation been designated by the Secretary as an additive that is not a human or animal carcinogen, or otherwise harmful to health under intended conditions of use, the manufacturer shall within 60 days of such action so advise the Secretary in writing. ‘‘(d) DATA LIST.— ‘‘(1) IN
GENERAL.—Not

later than 3 years

after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, and annually thereafter, the Secretary shall publish in a format that is understandable and not misleading to a lay

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34 1 2 3 4 5 6 7 8 9 10 11 12 13 14 person, and place on public display (in a manner determined by the Secretary) the list established under subsection (e). ‘‘(2) CONSUMER
RESEARCH.—The

Secretary

shall conduct periodic consumer research to ensure that the list published under paragraph (1) is not misleading to lay persons. Not later than 5 years after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, the Secretary shall submit to the appropriate committees of Congress a report on the results of such research, together with recommendations on whether such publication should be continued or modified. ‘‘(e) DATA COLLECTION.—Not later than 12 months

15 after the date of enactment of the Family Smoking Pre16 vention and Tobacco Control Act, the Secretary shall es17 tablish a list of harmful and potentially harmful constitu18 ents, including smoke constituents, to health in each to19 bacco product by brand and by quantity in each brand 20 and subbrand. The Secretary shall publish a public notice 21 requesting the submission by interested persons of sci22 entific and other information concerning the harmful and 23 potentially harmful constituents in tobacco products and 24 tobacco smoke.

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35 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17
‘‘SEC. 905. ANNUAL REGISTRATION.

‘‘(a) DEFINITIONS.—In this section: ‘‘(1) MANUFACTURE,
PREPARATION,

COMPOUNDING, OR PROCESSING.—The

term ‘manu-

facture, preparation, compounding, or processing’ shall include repackaging or otherwise changing the container, wrapper, or labeling of any tobacco product package in furtherance of the distribution of the tobacco product from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer or user. ‘‘(2) NAME.—The term ‘name’ shall include in the case of a partnership the name of each partner and, in the case of a corporation, the name of each corporate officer and director, and the State of incorporation. ‘‘(b) REGISTRATION
BY

OWNERS

AND

OPERATORS.—

18 On or before December 31 of each year every person who 19 owns or operates any establishment in any State engaged 20 in the manufacture, preparation, compounding, or proc21 essing of a tobacco product or tobacco products shall reg22 ister with the Secretary the name, places of business, and 23 all such establishments of that person. 24 25 ‘‘(c) REGISTRATION
TORS.—Every OF

NEW OWNERS

AND

OPERA-

person upon first engaging in the manufac-

26 ture, preparation, compounding, or processing of a tobacco
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36 1 product or tobacco products in any establishment owned 2 or operated in any State by that person shall immediately 3 register with the Secretary that person’s name, place of 4 business, and such establishment. 5 ‘‘(d) REGISTRATION OF ADDED ESTABLISHMENTS.—

6 Every person required to register under subsection (b) or 7 (c) shall immediately register with the Secretary any addi8 tional establishment which that person owns or operates 9 in any State and in which that person begins the manufac10 ture, preparation, compounding, or processing of a tobacco 11 product or tobacco products. 12 13 ‘‘(e) UNIFORM PRODUCT IDENTIFICATION SYSTEM.—The

Secretary may by regulation prescribe a uni-

14 form system for the identification of tobacco products and 15 may require that persons who are required to list such 16 tobacco products under subsection (i) shall list such to17 bacco products in accordance with such system. 18 19 ‘‘(f) PUBLIC ACCESS
TION.—The TO

REGISTRATION INFORMA-

Secretary shall make available for inspection,

20 to any person so requesting, any registration filed under 21 this section. 22 23 ‘‘(g) BIENNIAL INSPECTION
LISHMENTS.—Every OF

REGISTERED ESTAB-

establishment in any State registered

24 with the Secretary under this section shall be subject to 25 inspection under section 704, and every such establish-

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37 1 ment engaged in the manufacture, compounding, or proc2 essing of a tobacco product or tobacco products shall be 3 so inspected by 1 or more officers or employees duly des4 ignated by the Secretary at least once in the 2-year period 5 beginning with the date of registration of such establish6 ment under this section and at least once in every succes7 sive 2-year period thereafter. 8 9 ‘‘(h) FOREIGN ESTABLISHMENTS SHALL REG-

ISTER.—Any

establishment within any foreign country en-

10 gaged in the manufacture, preparation, compounding, or 11 processing of a tobacco product or tobacco products, shall 12 register under this section under regulations promulgated 13 by the Secretary. Such regulations shall require such es14 tablishment to provide the information required by sub15 section (i) of this section and shall include provisions for 16 registration of any such establishment upon condition that 17 adequate and effective means are available, by arrange18 ment with the government of such foreign country or oth19 erwise, to enable the Secretary to determine from time to 20 time whether tobacco products manufactured, prepared, 21 compounded, or processed in such establishment, if im22 ported or offered for import into the United States, shall 23 be refused admission on any of the grounds set forth in 24 section 801(a). 25 ‘‘(i) REGISTRATION INFORMATION.—

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38 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 ‘‘(1) PRODUCT
LIST.—Every

person who reg-

isters with the Secretary under subsection (b), (c), (d), or (h) shall, at the time of registration under any such subsection, file with the Secretary a list of all tobacco products which are being manufactured, prepared, compounded, or processed by that person for commercial distribution and which has not been included in any list of tobacco products filed by that person with the Secretary under this paragraph or paragraph (2) before such time of registration. Such list shall be prepared in such form and manner as the Secretary may prescribe and shall be accompanied by— ‘‘(A) in the case of a tobacco product contained in the applicable list with respect to which a tobacco product standard has been established under section 907 or which is subject to section 910, a reference to the authority for the marketing of such tobacco product and a copy of all labeling for such tobacco product; ‘‘(B) in the case of any other tobacco product contained in an applicable list, a copy of all consumer information and other labeling for such tobacco product, a representative sampling of advertisements for such tobacco product,

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39 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 and, upon request made by the Secretary for good cause, a copy of all advertisements for a particular tobacco product; and ‘‘(C) if the registrant filing a list has determined that a tobacco product contained in such list is not subject to a tobacco product standard established under section 907, a brief statement of the basis upon which the registrant made such determination if the Secretary requests such a statement with respect to that particular tobacco product. ‘‘(2) BIANNUAL
REPORT OF ANY CHANGE IN

PRODUCT LIST.—Each

person who registers with the

Secretary under this section shall report to the Secretary once during the month of June of each year and once during the month of December of each year the following: ‘‘(A) A list of each tobacco product introduced by the registrant for commercial distribution which has not been included in any list previously filed by that person with the Secretary under this subparagraph or paragraph (1). A list under this subparagraph shall list a tobacco product by its established name and

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40 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 shall be accompanied by the other information required by paragraph (1). ‘‘(B) If since the date the registrant last made a report under this paragraph that person has discontinued the manufacture, preparation, compounding, or processing for commercial distribution of a tobacco product included in a list filed under subparagraph (A) or paragraph (1), notice of such discontinuance, the date of such discontinuance, and the identity of its established name. ‘‘(C) If since the date the registrant reported under subparagraph (B) a notice of discontinuance that person has resumed the manufacture, preparation, compounding, or processing for commercial distribution of the tobacco product with respect to which such notice of discontinuance was reported, notice of such resumption, the date of such resumption, the identity of such tobacco product by established name, and other information required by paragraph (1), unless the registrant has previously reported such resumption to the Secretary under this subparagraph.

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41 1 2 3 4 5
TAIN

‘‘(D) Any material change in any information previously submitted under this paragraph or paragraph (1). ‘‘(j) REPORT PRECEDING INTRODUCTION SUBSTANTIALLY-EQUIVALENT
OF

CERINTO

PRODUCTS

6 INTERSTATE COMMERCE.— 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 ‘‘(1) IN
GENERAL.—Each

person who is re-

quired to register under this section and who proposes to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a tobacco product intended for human use that was not commercially marketed (other than for test marketing) in the United States as of June 1, 2003, shall, at least 90 days prior to making such introduction or delivery, report to the Secretary (in such form and manner as the Secretary shall prescribe)— ‘‘(A) the basis for such person’s determination that the tobacco product is substantially equivalent, within the meaning of section 910, to a tobacco product commercially marketed (other than for test marketing) in the United States as of June 1, 2003, that is in compliance with the requirements of this Act; and

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42 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 ‘‘(B) action taken by such person to comply with the requirements under section 907 that are applicable to the tobacco product. ‘‘(2) APPLICATION
2003 PRODUCTS.—A TO CERTAIN POST JUNE 1,

report under this subsection for

a tobacco product that was first introduced or delivered for introduction into interstate commerce for commercial distribution in the United States after June 1, 2003, and prior to the date that is 15 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act shall be submitted to the Secretary not later than 15 months after such date of enactment. ‘‘(3) EXEMPTIONS.— ‘‘(A) IN
GENERAL.—The

Secretary may by

regulation, exempt from the requirements of this subsection tobacco products that are modified by adding or deleting a tobacco additive, or increasing or decreasing the quantity of an existing tobacco additive, if the Secretary determines that— ‘‘(i) such modification would be a minor modification of a tobacco product authorized for sale under this Act;

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43 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 ‘‘(ii) a report under this subsection is not necessary to ensure that permitting the tobacco product to be marketed would be appropriate for protection of the public health; and ‘‘(iii) an exemption is otherwise appropriate. ‘‘(B) REGULATIONS.—Not later than 9 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, the Secretary shall issue regulations to implement this paragraph.
‘‘SEC. 906. GENERAL PROVISIONS RESPECTING CONTROL OF TOBACCO PRODUCTS.

‘‘(a) IN GENERAL.—Any requirement established by

16 or under section 902, 903, 905, or 909 applicable to a 17 tobacco product shall apply to such tobacco product until 18 the applicability of the requirement to the tobacco product 19 has been changed by action taken under section 907, sec20 tion 910, section 911, or subsection (d) of this section, 21 and any requirement established by or under section 902, 22 903, 905, or 909 which is inconsistent with a requirement 23 imposed on such tobacco product under section 907, sec24 tion 910, section 911, or subsection (d) of this section 25 shall not apply to such tobacco product.

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44 1 2 ‘‘(b) INFORMATION
MENT.—Each ON

PUBLIC ACCESS

AND

COM-

notice of proposed rulemaking under section

3 907, 908, 909, 910, or 911 or under this section, any 4 other notice which is published in the Federal Register 5 with respect to any other action taken under any such sec6 tion and which states the reasons for such action, and 7 each publication of findings required to be made in con8 nection with rulemaking under any such section shall set 9 forth— 10 11 12 13 14 15 16 17 18 19 20 21 ‘‘(1) the manner in which interested persons may examine data and other information on which the notice or findings is based; and ‘‘(2) the period within which interested persons may present their comments on the notice or findings (including the need therefore) orally or in writing, which period shall be at least 60 days but may not exceed 90 days unless the time is extended by the Secretary by a notice published in the Federal Register stating good cause therefore. ‘‘(c) LIMITED CONFIDENTIALITY
TION.—Any OF

INFORMA-

information reported to or otherwise obtained

22 by the Secretary or the Secretary’s representative under 23 section 903, 904, 907, 908, 909, 910, 911, or 704, or 24 under subsection (e) or (f) of this section, which is exempt 25 from disclosure under subsection (a) of section 552 of title

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45 1 5, United States Code, by reason of subsection (b)(4) of 2 that section shall be considered confidential and shall not 3 be disclosed, except that the information may be disclosed 4 to other officers or employees concerned with carrying out 5 this chapter, or when relevant in any proceeding under 6 this chapter. 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 ‘‘(d) RESTRICTIONS.— ‘‘(1) IN
GENERAL.—The

Secretary may by reg-

ulation require restrictions on the sale and distribution of a tobacco product, including restrictions on the access to, and the advertising and promotion of, the tobacco product, if the Secretary determines that such regulation would be appropriate for the protection of the public health. The Secretary may by regulation impose restrictions on the advertising and promotion of a tobacco product consistent with and to full extent permitted by the first amendment to the Constitution. The finding as to whether such regulation would be appropriate for the protection of the public health shall be determined with respect to the risks and benefits to the population as a whole, including users and non-users of the tobacco product, and taking into account—

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46 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 ‘‘(A) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and ‘‘(B) the increased or decreased likelihood that those who do not use tobacco products will start using such products. No such regulation may require that the sale or distribution of a tobacco product be limited to the written or oral authorization of a practitioner licensed by law to prescribe medical products. ‘‘(2) LABEL
STATEMENTS.—The

label of a to-

bacco product shall bear such appropriate statements of the restrictions required by a regulation under subsection (a) as the Secretary may in such regulation prescribe. ‘‘(3) LIMITATIONS.— ‘‘(A) IN
GENERAL.—No

restrictions under

paragraph (1) may— ‘‘(i) prohibit the sale of any tobacco product in face-to-face transactions by a specific category of retail outlets; or ‘‘(ii) establish a minimum age of sale of tobacco products to any person older than 18 years of age.

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47 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 ‘‘(B) MATCHBOOKS.—For purposes of any regulations issued by the Secretary, matchbooks of conventional size containing not more than 20 paper matches, and which are customarily given away for free with the purchase of tobacco products shall be considered as adult written publications which shall be permitted to contain advertising. Notwithstanding the preceding sentence, if the Secretary finds that such treatment of matchbooks is not appropriate for the protection of the public health, the Secretary may determine by regulation that matchbooks shall not be considered adult written publications. ‘‘(e) GOOD MANUFACTURING PRACTICE REQUIREMENTS.—

‘‘(1) METHODS,
CONFORM.—

FACILITIES, AND CONTROLS TO

‘‘(A) IN

GENERAL.—The

Secretary may, in

accordance with subparagraph (B), prescribe regulations (which may differ based on the type of tobacco product involved) requiring that the methods used in, and the facilities and controls used for, the manufacture, pre-production design validation (including a process to assess

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48 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 the performance of a tobacco product), packing and storage of a tobacco product, conform to current good manufacturing practice, as prescribed in such regulations, to assure that the public health is protected and that the tobacco product is in compliance with this chapter. Good manufacturing practices may include the testing of raw tobacco for pesticide chemical residues regardless of whether a tolerance for such chemical residues has been established. ‘‘(B) shall— ‘‘(i) before promulgating any regulation under subparagraph (A), afford the Tobacco Products Scientific Advisory Committee an opportunity to submit recommendations with respect to the regulation proposed to be promulgated; ‘‘(ii) before promulgating any regulation under subparagraph (A), afford opportunity for an oral hearing; ‘‘(iii) provide the advisory committee a reasonable time to make its recommendation with respect to proposed regulations under subparagraph (A); and REQUIREMENTS.—The Secretary

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49 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 ‘‘(iv) in establishing the effective date of a regulation promulgated under this subsection, take into account the differences in the manner in which the different types of tobacco products have historically been produced, the financial resources of the different tobacco product manufacturers, and the state of their existing manufacturing facilities, and shall provide for a reasonable period of time for such manufacturers to conform to good manufacturing practices. ‘‘(2) EXEMPTIONS;
VARIANCES.—

‘‘(A) PETITION.—Any person subject to any requirement prescribed under paragraph (1) may petition the Secretary for a permanent or temporary exemption or variance from such requirement. Such a petition shall be submitted to the Secretary in such form and manner as the Secretary shall prescribe and shall— ‘‘(i) in the case of a petition for an exemption from a requirement, set forth the basis for the petitioner’s determination that compliance with the requirement is not required to assure that the tobacco

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50 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 product will be in compliance with this chapter; ‘‘(ii) in the case of a petition for a variance from a requirement, set forth the methods proposed to be used in, and the facilities and controls proposed to be used for, the manufacture, packing, and storage of the tobacco product in lieu of the methods, facilities, and controls prescribed by the requirement; and ‘‘(iii) contain such other information as the Secretary shall prescribe. ‘‘(B) REFERRAL
TO THE TOBACCO PROD-

UCTS SCIENTIFIC ADVISORY COMMITTEE.—The

Secretary may refer to the Tobacco Products Scientific Advisory Committee any petition submitted under subparagraph (A). The Tobacco Products Scientific Advisory Committee shall report its recommendations to the Secretary with respect to a petition referred to it within 60 days after the date of the petition’s referral. Within 60 days after— ‘‘(i) the date the petition was submitted to the Secretary under subparagraph (A); or

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51 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 ‘‘(ii) the day after the petition was referred to the Tobacco Products Scientific Advisory Committee, whichever occurs later, the Secretary shall by order either deny the petition or approve it. ‘‘(C) APPROVAL.—The Secretary may approve— ‘‘(i) a petition for an exemption for a tobacco product from a requirement if the Secretary determines that compliance with such requirement is not required to assure that the tobacco product will be in compliance with this chapter; and ‘‘(ii) a petition for a variance for a tobacco product from a requirement if the Secretary determines that the methods to be used in, and the facilities and controls to be used for, the manufacture, packing, and storage of the tobacco product in lieu of the methods, controls, and facilities prescribed by the requirement are sufficient to assure that the tobacco product will be in compliance with this chapter. ‘‘(D) CONDITIONS.—An order of the Secretary approving a petition for a variance shall

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52 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 prescribe such conditions respecting the methods used in, and the facilities and controls used for, the manufacture, packing, and storage of the tobacco product to be granted the variance under the petition as may be necessary to assure that the tobacco product will be in compliance with this chapter. ‘‘(E) HEARING.—After the issuance of an order under subparagraph (B) respecting a petition, the petitioner shall have an opportunity for an informal hearing on such order. ‘‘(3) COMPLIANCE.—Compliance with requirements under this subsection shall not be required before the period ending 3 years after the date of enactment of the Family Smoking Prevention and Tobacco Control Act. ‘‘(f) RESEARCH AND DEVELOPMENT.—The Secretary

18 may enter into contracts for research, testing, and dem19 onstrations respecting tobacco products and may obtain 20 tobacco products for research, testing, and demonstration 21 purposes without regard to section 3324(a) and (b) of title 22 31, United States Code, and section 5 of title 41, United 23 States Code. 24 25
‘‘SEC. 907. TOBACCO PRODUCT STANDARDS.

‘‘(a) IN GENERAL.—

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53 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 ‘‘(1) SPECIAL
RULE FOR CIGARETTES.—A

ciga-

rette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke. Nothing in this subparagraph shall be construed to limit the Secretary’s authority to take action under this section or other sections of this Act applicable to menthol or any artificial or natural flavor, herb, or spice not specified in this paragraph. ‘‘(2) REVISION
ARDS.—The OF TOBACCO PRODUCT STAND-

Secretary may revise the tobacco prod-

uct standards in paragraph (1) in accordance with subsection (b). ‘‘(3) TOBACCO
PRODUCT STANDARDS.—The

Secretary may adopt tobacco product standards in addition to those in paragraph (1) if the Secretary finds that a tobacco product standard is appropriate for the protection of the public health. This finding shall be determined with respect to the risks and

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54 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 benefits to the population as a whole, including users and non-users of the tobacco product, and taking into account— ‘‘(A) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and ‘‘(B) the increased or decreased likelihood that those who do not use tobacco products will start using such products. ‘‘(4) CONTENT
ARDS.—A OF TOBACCO PRODUCT STAND-

tobacco product standard established

under this section for a tobacco product— ‘‘(A) shall include provisions that are appropriate for the protection of the public health, including provisions, where appropriate— ‘‘(i) for the reduction of nicotine yields of the product; ‘‘(ii) for the reduction or elimination of other constituents, including smoke constituents, or harmful components of the product; or ‘‘(iii) relating to any other requirement under (B); ‘‘(B) shall, where appropriate for the protection of the public health, include—

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55 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 ‘‘(i) provisions respecting the construction, components, ingredients, additives, constituents, including smoke constituents, and properties of the tobacco product; ‘‘(ii) provisions for the testing (on a sample basis or, if necessary, on an individual basis) of the tobacco product; ‘‘(iii) provisions for the measurement of the tobacco product characteristics of the tobacco product; ‘‘(iv) provisions requiring that the results of each or of certain of the tests of the tobacco product required to be made under clause (ii) show that the tobacco product is in conformity with the portions of the standard for which the test or tests were required; and ‘‘(v) a provision requiring that the sale and distribution of the tobacco product be restricted but only to the extent that the sale and distribution of a tobacco product may be restricted under a regulation under section 906(d); and

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56 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 ‘‘(C) shall, where appropriate, require the use and prescribe the form and content of labeling for the proper use of the tobacco product. ‘‘(5) PERIODIC
RE-EVALUATION OF TOBACCO

PRODUCT STANDARDS.—The

Secretary shall provide

for periodic evaluation of tobacco product standards established under this section to determine whether such standards should be changed to reflect new medical, scientific, or other technological data. The Secretary may provide for testing under paragraph (4)(B) by any person. ‘‘(6) INVOLVEMENT
FORMED PERSONS.—In OF OTHER AGENCIES; IN-

carrying out duties under

this section, the Secretary shall endeavor to— ‘‘(A) use personnel, facilities, and other technical support available in other Federal agencies; ‘‘(B) consult with other Federal agencies concerned with standard-setting and other nationally or internationally recognized standardsetting entities; and ‘‘(C) invite appropriate participation,

through joint or other conferences, workshops, or other means, by informed persons representative of scientific, professional, industry, agri-

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57 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 cultural, or consumer organizations who in the Secretary’s judgment can make a significant contribution. ‘‘(b) ESTABLISHMENT OF STANDARDS.— ‘‘(1) NOTICE.— ‘‘(A) IN
GENERAL.—The

Secretary shall

publish in the Federal Register a notice of proposed rulemaking for the establishment, amendment, or revocation of any tobacco product standard. ‘‘(B) REQUIREMENTS
OF NOTICE.—A

no-

tice of proposed rulemaking for the establishment or amendment of a tobacco product standard for a tobacco product shall— ‘‘(i) set forth a finding with supporting justification that the tobacco product standard is appropriate for the protection of the public health; ‘‘(ii) set forth proposed findings with respect to the risk of illness or injury that the tobacco product standard is intended to reduce or eliminate; and ‘‘(iii) invite interested persons to submit an existing tobacco product standard for the tobacco product, including a draft

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58 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 or proposed tobacco product standard, for consideration by the Secretary. ‘‘(C) STANDARD.—Upon a determination by the Secretary that an additive, constituent (including smoke constituent), or other component of the product that is the subject of the proposed tobacco product standard is harmful, it shall be the burden of any party challenging the proposed standard to prove that the proposed standard will not reduce or eliminate the risk of illness or injury. ‘‘(D) FINDING.—A notice of proposed rulemaking for the revocation of a tobacco product standard shall set forth a finding with supporting justification that the tobacco product standard is no longer appropriate for the protection of the public health. ‘‘(E) CONSIDERATION
BY SECRETARY.—

The Secretary shall consider all information submitted in connection with a proposed standard, including information concerning the countervailing effects of the tobacco product standard on the health of adolescent tobacco users, adult tobacco users, or non-tobacco users, such as the creation of a significant demand for con-

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59 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 traband or other tobacco products that do not meet the requirements of this chapter and the significance of such demand, and shall issue the standard if the Secretary determines that the standard would be appropriate for the protection of the public health. ‘‘(F) COMMENT.—The Secretary shall provide for a comment period of not less than 60 days. ‘‘(2) PROMULGATION.— ‘‘(A) IN
GENERAL.—After

the expiration of

the period for comment on a notice of proposed rulemaking published under paragraph (1) respecting a tobacco product standard and after consideration of such comments and any report from the Tobacco Products Scientific Advisory Committee, the Secretary shall— ‘‘(i) promulgate a regulation establishing a tobacco product standard and publish in the Federal Register findings on the matters referred to in paragraph (1); or ‘‘(ii) publish a notice terminating the proceeding for the development of the

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60 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 standard together with the reasons for such termination. ‘‘(B) EFFECTIVE
DATE.—A

regulation es-

tablishing a tobacco product standard shall set forth the date or dates upon which the standard shall take effect, but no such regulation may take effect before 1 year after the date of its publication unless the Secretary determines that an earlier effective date is necessary for the protection of the public health. Such date or dates shall be established so as to minimize, consistent with the public health, economic loss to, and disruption or dislocation of, domestic and international trade. ‘‘(3) POWER
RESERVED TO CONGRESS.—Be-

cause of the importance of a decision of the Secretary to issue a regulation establishing a tobacco product standard— ‘‘(A) banning all cigarettes, all smokeless tobacco products, all little cigars, all cigars other than little cigars, all pipe tobacco, or all roll-your-own tobacco products; or ‘‘(B) requiring the reduction of nicotine yields of a tobacco product to zero, Congress expressly reserves to itself such power.

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61 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 ‘‘(4) AMENDMENT;
REVOCATION.—

‘‘(A) AUTHORITY.—The Secretary, upon the Secretary’s own initiative or upon petition of an interested person may by a regulation, promulgated in accordance with the requirements of paragraphs (1) and (2)(B), amend or revoke a tobacco product standard. ‘‘(B) EFFECTIVE
DATE.—The

Secretary

may declare a proposed amendment of a tobacco product standard to be effective on and after its publication in the Federal Register and until the effective date of any final action taken on such amendment if the Secretary determines that making it so effective is in the public interest. ‘‘(5) REFERENCE The Secretary may— ‘‘(A) on the Secretary’s own initiative, refer a proposed regulation for the establishment, amendment, or revocation of a tobacco product standard; or ‘‘(B) upon the request of an interested person which demonstrates good cause for referral and which is made before the expiration of the
TO ADVISORY COMMITTEE.—

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62 1 2 period for submission of comments on such proposed regulation,

3 refer such proposed regulation to the Tobacco Products 4 Scientific Advisory Committee, for a report and rec5 ommendation with respect to any matter involved in the 6 proposed regulation which requires the exercise of sci7 entific judgment. If a proposed regulation is referred 8 under this paragraph to the Tobacco Products Scientific 9 Advisory Committee, the Secretary shall provide the advi10 sory committee with the data and information on which 11 such proposed regulation is based. The Tobacco Products 12 Scientific Advisory Committee shall, within 60 days after 13 the referral of a proposed regulation and after inde14 pendent study of the data and information furnished to 15 it by the Secretary and other data and information before 16 it, submit to the Secretary a report and recommendation 17 respecting such regulation, together with all underlying 18 data and information and a statement of the reason or 19 basis for the recommendation. A copy of such report and 20 recommendation shall be made public by the Secretary. 21 22
‘‘SEC. 908. NOTIFICATION AND OTHER REMEDIES.

‘‘(a) NOTIFICATION.—If the Secretary determines

23 that— 24 25 ‘‘(1) a tobacco product which is introduced or delivered for introduction into interstate commerce

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63 1 2 3 4 5 6 7 for commercial distribution presents an unreasonable risk of substantial harm to the public health; and ‘‘(2) notification under this subsection is necessary to eliminate the unreasonable risk of such harm and no more practicable means is available under the provisions of this chapter (other than this section) to eliminate such risk,

8 the Secretary may issue such order as may be necessary 9 to assure that adequate notification is provided in an ap10 propriate form, by the persons and means best suited 11 under the circumstances involved, to all persons who 12 should properly receive such notification in order to elimi13 nate such risk. The Secretary may order notification by 14 any appropriate means, including public service announce15 ments. Before issuing an order under this subsection, the 16 Secretary shall consult with the persons who are to give 17 notice under the order. 18 ‘‘(b) NO EXEMPTION FROM OTHER LIABILITY.—

19 Compliance with an order issued under this section shall 20 not relieve any person from liability under Federal or 21 State law. In awarding damages for economic loss in an 22 action brought for the enforcement of any such liability, 23 the value to the plaintiff in such action of any remedy 24 provided under such order shall be taken into account. 25 ‘‘(c) RECALL AUTHORITY.—

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64 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 ‘‘(1) IN
GENERAL.—If

the Secretary finds that

there is a reasonable probability that a tobacco product contains a manufacturing or other defect not ordinarily contained in tobacco products on the market that would cause serious, adverse health consequences or death, the Secretary shall issue an order requiring the appropriate person (including the manufacturers, importers, distributors, or retailers of the tobacco product) to immediately cease distribution of such tobacco product. The order shall provide the person subject to the order with an opportunity for an informal hearing, to be held not later than 10 days after the date of the issuance of the order, on the actions required by the order and on whether the order should be amended to require a recall of such tobacco product. If, after providing an opportunity for such a hearing, the Secretary determines that inadequate grounds exist to support the actions required by the order, the Secretary shall vacate the order. ‘‘(2) AMENDMENT
CALL.— OF ORDER TO REQUIRE RE-

‘‘(A) IN

GENERAL.—If,

after providing an

opportunity for an informal hearing under paragraph (1), the Secretary determines that

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65 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 the order should be amended to include a recall of the tobacco product with respect to which the order was issued, the Secretary shall, except as provided in subparagraph (B), amend the order to require a recall. The Secretary shall specify a timetable in which the tobacco product recall will occur and shall require periodic reports to the Secretary describing the progress of the recall. ‘‘(B) NOTICE.—An amended order under subparagraph (A)— ‘‘(i) shall not include recall of a tobacco product from individuals; and ‘‘(ii) shall provide for notice to persons subject to the risks associated with the use of such tobacco product. In providing the notice required by clause (ii), the Secretary may use the assistance of retailers and other persons who distributed such tobacco product. If a significant number of such persons cannot be identified, the Secretary shall notify such persons under section 705(b). ‘‘(3) REMEDY
NOT EXCLUSIVE.—The

remedy

provided by this subsection shall be in addition to remedies provided by subsection (a) of this section.

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66 1 2 3
‘‘SEC. 909. RECORDS AND REPORTS ON TOBACCO PRODUCTS.

‘‘(a) IN GENERAL.—Every person who is a tobacco

4 product manufacturer or importer of a tobacco product 5 shall establish and maintain such records, make such re6 ports, and provide such information, as the Secretary may 7 by regulation reasonably require to assure that such to8 bacco product is not adulterated or misbranded and to 9 otherwise protect public health. Regulations prescribed 10 under the preceding sentence— 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 ‘‘(1) may require a tobacco product manufacturer or importer to report to the Secretary whenever the manufacturer or importer receives or otherwise becomes aware of information that reasonably suggests that one of its marketed tobacco products may have caused or contributed to a serious unexpected adverse experience associated with the use of the product or any significant increase in the frequency of a serious, expected adverse product experience; ‘‘(2) shall require reporting of other significant adverse tobacco product experiences as determined by the Secretary to be necessary to be reported; ‘‘(3) shall not impose requirements unduly burdensome to a tobacco product manufacturer or importer, taking into account the cost of complying
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67 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 with such requirements and the need for the protection of the public health and the implementation of this chapter; ‘‘(4) when prescribing the procedure for making requests for reports or information, shall require that each request made under such regulations for submission of a report or information to the Secretary state the reason or purpose for such request and identify to the fullest extent practicable such report or information; ‘‘(5) when requiring submission of a report or information to the Secretary, shall state the reason or purpose for the submission of such report or information and identify to the fullest extent practicable such report or information; and ‘‘(6) may not require that the identity of any patient or user be disclosed in records, reports, or information required under this subsection unless required for the medical welfare of an individual, to determine risks to public health of a tobacco product, or to verify a record, report, or information submitted under this chapter.

23 In prescribing regulations under this subsection, the Sec24 retary shall have due regard for the professional ethics of 25 the medical profession and the interests of patients. The

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68 1 prohibitions of paragraph (6) continue to apply to records, 2 reports, and information concerning any individual who 3 has been a patient, irrespective of whether or when he 4 ceases to be a patient. 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 ‘‘(b) REPORTS ‘‘(1) IN
OF

REMOVALS

AND

CORRECTIONS.—

GENERAL.—Except

as provided in para-

graph (2), the Secretary shall by regulation require a tobacco product manufacturer or importer of a tobacco product to report promptly to the Secretary any corrective action taken or removal from the market of a tobacco product undertaken by such manufacturer or importer if the removal or correction was undertaken— ‘‘(A) to reduce a risk to health posed by the tobacco product; or ‘‘(B) to remedy a violation of this chapter caused by the tobacco product which may present a risk to health. A tobacco product manufacturer or importer of a tobacco product who undertakes a corrective action or removal from the market of a tobacco product which is not required to be reported under this subsection shall keep a record of such correction or removal. ‘‘(2) EXCEPTION.—No report of the corrective action or removal of a tobacco product may be re-

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69 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 quired under paragraph (1) if a report of the corrective action or removal is required and has been submitted under subsection (a).
‘‘SEC. 910. APPLICATION FOR REVIEW OF CERTAIN TOBACCO PRODUCTS.

‘‘(a) IN GENERAL.— ‘‘(1) NEW
TOBACCO PRODUCT DEFINED.—For

purposes of this section the term ‘new tobacco product’ means— ‘‘(A) any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of June 1, 2003; or ‘‘(B) any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after June 1, 2003. ‘‘(2) PREMARKET ‘‘(A) NEW
APPROVAL REQUIRED.— PRODUCTS.—Approval

under

this section of an application for premarket ap-

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70 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 proval for any new tobacco product is required unless— ‘‘(i) the manufacturer has submitted a report under section 905(j); and ‘‘(ii) the Secretary has issued an order that the tobacco product— ‘‘(I) is substantially equivalent to a tobacco product commercially marketed (other than for test marketing) in the United States as of June 1, 2003; and ‘‘(II)(aa) is in compliance with the requirements of this Act; or ‘‘(bb) is exempt from the requirements of section 905(j) pursuant to a regulation 905(j)(3). ‘‘(B) APPLICATION
TO CERTAIN POST

issued

under

section

JUNE 1, 2003 PRODUCTS.—Subparagraph

(A)

shall not apply to a tobacco product— ‘‘(i) that was first introduced or delivered for introduction into interstate commerce for commercial distribution in the United States after June 1, 2003, and prior to the date that is 15 months after

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71 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 the date of enactment of the Family Smoking Prevention and Tobacco Control Act; and ‘‘(ii) for which a report was submitted under section 905(j) within such 15-month period, until the Secretary issues an order that the tobacco product is not substantially equivalent. ‘‘(3) SUBSTANTIALLY ‘‘(A) IN
EQUIVALENT DEFINED.—

GENERAL.—In

this section and

section 905(j), the terms ‘substantially equivalent’ or ‘substantial equivalence’ mean, with respect to the tobacco product being compared to the predicate tobacco product, that the Secretary by order has found that the tobacco product— ‘‘(i) has the same characteristics as the predicate tobacco product; or ‘‘(ii) has different characteristics and the information submitted contains information, including clinical data if deemed necessary by the Secretary, that demonstrates that it is not appropriate to regulate the product under this section be-

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72 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 cause the product does not raise different questions of public health. ‘‘(B) CHARACTERISTICS.—In subpara-

graph (A), the term ‘characteristics’ means the materials, ingredients, design, composition,

heating source, or other features of a tobacco product. ‘‘(C) LIMITATION.—A tobacco product may not be found to be substantially equivalent to a predicate tobacco product that has been removed from the market at the initiative of the Secretary or that has been determined by a judicial order to be misbranded or adulterated. ‘‘(4) HEALTH
INFORMATION.—

‘‘(A) SUMMARY.—As part of a submission under section 905(j) respecting a tobacco product, the person required to file a premarket notification under such section shall provide an adequate summary of any health information related to the tobacco product or state that such information will be made available upon request by any person. ‘‘(B) REQUIRED
INFORMATION.—Any

sum-

mary under subparagraph (A) respecting a tobacco product shall contain detailed information

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73 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 regarding data concerning adverse health effects and shall be made available to the public by the Secretary within 30 days of the issuance of a determination that such tobacco product is substantially equivalent to another tobacco product. ‘‘(b) APPLICATION.— ‘‘(1) CONTENTS.—An application for premarket approval shall contain— ‘‘(A) full reports of all information, published or known to, or which should reasonably be known to, the applicant, concerning investigations which have been made to show the health risks of such tobacco product and whether such tobacco product presents less risk than other tobacco products; ‘‘(B) a full statement of the components, ingredients, additives, and properties, and of the principle or principles of operation, of such tobacco product; ‘‘(C) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of, such tobacco product;

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74 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 ‘‘(D) an identifying reference to any tobacco product standard under section 907 which would be applicable to any aspect of such tobacco product, and either adequate information to show that such aspect of such tobacco product fully meets such tobacco product standard or adequate information to justify any deviation from such standard; ‘‘(E) such samples of such tobacco product and of components thereof as the Secretary may reasonably require; ‘‘(F) specimens of the labeling proposed to be used for such tobacco product; and ‘‘(G) such other information relevant to the subject matter of the application as the Secretary may require. ‘‘(2) REFERENCE
TO TOBACCO PRODUCTS SCI-

ENTIFIC ADVISORY COMMITTEE.—Upon

receipt of an

application meeting the requirements set forth in paragraph (1), the Secretary— ‘‘(A) may, on the Secretary’s own initiative; or ‘‘(B) may, upon the request of an applicant,

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75 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 refer such application to the Tobacco Products Scientific Advisory Committee for reference and for submission (within such period as the Secretary may establish) of a report and recommendation respecting approval of the application, together with all underlying data and the reasons or basis for the recommendation. ‘‘(c) ACTION ON APPLICATION.— ‘‘(1) DEADLINE.— ‘‘(A) IN
GENERAL.—As

promptly as pos-

sible, but in no event later than 180 days after the receipt of an application under subsection (b), the Secretary, after considering the report and recommendation submitted under paragraph (2) of such subsection, shall— ‘‘(i) issue an order approving the application if the Secretary finds that none of the grounds for denying approval specified in paragraph (2) of this subsection applies; or ‘‘(ii) deny approval of the application if the Secretary finds (and sets forth the basis for such finding as part of or accompanying such denial) that 1 or more

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76 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 grounds for denial specified in paragraph (2) of this subsection apply. ‘‘(B) RESTRICTIONS
TRIBUTION.—An ON SALE AND DIS-

order approving an application

for a tobacco product may require as a condition to such approval that the sale and distribution of the tobacco product be restricted but only to the extent that the sale and distribution of a tobacco product may be restricted under a regulation under section 906(d). ‘‘(2) DENIAL
OF APPROVAL.—The

Secretary

shall deny approval of an application for a tobacco product if, upon the basis of the information submitted to the Secretary as part of the application and any other information before the Secretary with respect to such tobacco product, the Secretary finds that— ‘‘(A) there is a lack of a showing that permitting such tobacco product to be marketed would be appropriate for the protection of the public health; ‘‘(B) the methods used in, or the facilities or controls used for, the manufacture, processing, or packing of such tobacco product do

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77 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 not conform to the requirements of section 906(e); ‘‘(C) based on a fair evaluation of all material facts, the proposed labeling is false or misleading in any particular; or ‘‘(D) such tobacco product is not shown to conform in all respects to a tobacco product standard in effect under section 907, compliance with which is a condition to approval of the application, and there is a lack of adequate information to justify the deviation from such standard. ‘‘(3) DENIAL
INFORMATION.—Any

denial of an

application shall, insofar as the Secretary determines to be practicable, be accompanied by a statement informing the applicant of the measures required to place such application in approvable form (which measures may include further research by the applicant in accordance with 1 or more protocols prescribed by the Secretary). ‘‘(4) BASIS
FOR FINDING.—For

purposes of

this section, the finding as to whether approval of a tobacco product is appropriate for the protection of the public health shall be determined with respect to the risks and benefits to the population as a whole,

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78 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 including users and nonusers of the tobacco product, and taking into account— ‘‘(A) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and ‘‘(B) the increased or decreased likelihood that those who do not use tobacco products will start using such products. ‘‘(5) BASIS
FOR ACTION.—

‘‘(A) INVESTIGATIONS.—For purposes of paragraph (2)(A), whether permitting a tobacco product to be marketed would be appropriate for the protection of the public health shall, when appropriate, be determined on the basis of well-controlled investigations, which may include 1 or more clinical investigations by experts qualified by training and experience to evaluate the tobacco product. ‘‘(B) OTHER
EVIDENCE.—If

the Secretary

determines that there exists valid scientific evidence (other than evidence derived from investigations described in subparagraph (A)) which is sufficient to evaluate the tobacco product the Secretary may authorize that the determination

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79 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 for purposes of paragraph (2)(A) be made on the basis of such evidence. ‘‘(d) WITHDRAWAL AND TEMPORARY SUSPENSION.— ‘‘(1) IN
GENERAL.—The

Secretary shall, upon

obtaining, where appropriate, advice on scientific matters from an advisory committee, and after due notice and opportunity for informal hearing to the holder of an approved application for a tobacco product, issue an order withdrawing approval of the application if the Secretary finds— ‘‘(A) that the continued marketing of such tobacco product no longer is appropriate for the protection of the public health; ‘‘(B) that the application contained or was accompanied by an untrue statement of a material fact; ‘‘(C) that the applicant— ‘‘(i) has failed to establish a system for maintaining records, or has repeatedly or deliberately failed to maintain records or to make reports, required by an applicable regulation under section 909; ‘‘(ii) has refused to permit access to, or copying or verification of, such records as required by section 704; or

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80 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 ‘‘(iii) has not complied with the requirements of section 905; ‘‘(D) on the basis of new information before the Secretary with respect to such tobacco product, evaluated together with the evidence before the Secretary when the application was approved, that the methods used in, or the facilities and controls used for, the manufacture, processing, packing, or installation of such tobacco product do not conform with the requirements of section 906(e) and were not brought into conformity with such requirements within a reasonable time after receipt of written notice from the Secretary of nonconformity; ‘‘(E) on the basis of new information before the Secretary, evaluated together with the evidence before the Secretary when the application was approved, that the labeling of such tobacco product, based on a fair evaluation of all material facts, is false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the Secretary of such fact; or ‘‘(F) on the basis of new information before the Secretary, evaluated together with the

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81 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 evidence before the Secretary when the application was approved, that such tobacco product is not shown to conform in all respects to a tobacco product standard which is in effect under section 907, compliance with which was a condition to approval of the application, and that there is a lack of adequate information to justify the deviation from such standard. ‘‘(2) APPEAL.—The holder of an application subject to an order issued under paragraph (1) withdrawing approval of the application may, by petition filed on or before the 30th day after the date upon which such holder receives notice of such withdrawal, obtain review thereof in accordance with subsection (e). ‘‘(3) TEMPORARY
SUSPENSION.—If,

after pro-

viding an opportunity for an informal hearing, the Secretary determines there is reasonable probability that the continuation of distribution of a tobacco product under an approved application would cause serious, adverse health consequences or death, that is greater than ordinarily caused by tobacco products on the market, the Secretary shall by order temporarily suspend the approval of the application approved under this section. If the Secretary issues

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82 1 2 3 4 such an order, the Secretary shall proceed expeditiously under paragraph (1) to withdraw such application. ‘‘(e) SERVICE
OF

ORDER.—An order issued by the

5 Secretary under this section shall be served— 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 ‘‘(1) in person by any officer or employee of the department designated by the Secretary; or ‘‘(2) by mailing the order by registered mail or certified mail addressed to the applicant at the applicant’s last known address in the records of the Secretary. ‘‘(f) RECORDS.— ‘‘(1) ADDITIONAL
INFORMATION.—In

the case

of any tobacco product for which an approval of an application filed under subsection (b) is in effect, the applicant shall establish and maintain such records, and make such reports to the Secretary, as the Secretary may by regulation, or by order with respect to such application, prescribe on the basis of a finding that such records and reports are necessary in order to enable the Secretary to determine, or facilitate a determination of, whether there is or may be grounds for withdrawing or temporarily suspending such approval.

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83 1 2 3 4 5 6 7 8 9 ‘‘(2) ACCESS
TO RECORDS.—Each

person re-

quired under this section to maintain records, and each person in charge or custody thereof, shall, upon request of an officer or employee designated by the Secretary, permit such officer or employee at all reasonable times to have access to and copy and verify such records. ‘‘(g) INVESTIGATIONAL TOBACCO PRODUCT EXEMPTION FOR

INVESTIGATIONAL USE.—The Secretary may

10 exempt tobacco products intended for investigational use 11 from the provisions of this chapter under such conditions 12 as the Secretary may by regulation prescribe. 13 14
‘‘SEC. 911. MODIFIED RISK TOBACCO PRODUCTS.

‘‘(a) IN GENERAL.—No person may introduce or de-

15 liver for introduction into interstate commerce any modi16 fied risk tobacco product unless approval of an application 17 filed pursuant to subsection (d) is effective with respect 18 to such product. 19 20 21 22 23 24 25 ‘‘(b) DEFINITIONS.—In this section: ‘‘(1) MODIFIED
RISK TOBACCO PRODUCT.—The

term ‘modified risk tobacco product’ means any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.

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84 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 ‘‘(2) SOLD
OR DISTRIBUTED.— GENERAL.—With

‘‘(A) IN

respect to a to-

bacco product, the term ‘sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products’ means a tobacco product— ‘‘(i) the label, labeling, or advertising of which represents explicitly or implicitly that— ‘‘(I) the tobacco product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products; ‘‘(II) the tobacco product or its smoke contains a reduced level of a substance or presents a reduced exposure to a substance; or ‘‘(III) the tobacco product or its smoke does not contain or is free of a substance; ‘‘(ii) the label, labeling, or advertising of which uses the descriptors ‘light’, ‘mild’, or ‘low’ or similar descriptors; or

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85 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 ‘‘(iii) the tobacco product manufacturer of which has taken any action directed to consumers through the media or otherwise, other than by means of the tobacco product’s label, labeling or advertising, after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, respecting the product that would be reasonably expected to result in consumers believing that the tobacco product or its smoke may present a lower risk of disease or is less harmful than one or more commercially marketed tobacco products, or presents a reduced exposure to, or does not contain or is free of, a substance or substances. ‘‘(B) LIMITATION.—No tobacco product shall be considered to be ‘sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products’, except as described in subparagraph (A). ‘‘(c) TOBACCO DEPENDENCE PRODUCTS.—A product

24 that is intended to be used for the treatment of tobacco 25 dependence, including smoking cessation, is not a modified

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86 1 risk tobacco product under this section and is subject to 2 the requirements of chapter V. 3 ‘‘(d) FILING.—Any person may file with the Sec-

4 retary an application for a modified risk tobacco product. 5 Such application shall include— 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 ‘‘(1) a description of the proposed product and any proposed advertising and labeling; ‘‘(2) the conditions for using the product; ‘‘(3) the formulation of the product; ‘‘(4) sample product labels and labeling; ‘‘(5) all documents (including underlying scientific information) relating to research findings conducted, supported, or possessed by the tobacco product manufacturer relating to the effect of the product on tobacco related diseases and health-related conditions, including information both favorable and unfavorable to the ability of the product to reduce risk or exposure and relating to human health; ‘‘(6) data and information on how consumers actually use the tobacco product; and ‘‘(7) such other information as the Secretary may require. ‘‘(e) PUBLIC AVAILABILITY.—The Secretary shall

25 make the application described in subsection (d) publicly

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87 1 available (except matters in the application which are 2 trade secrets or otherwise confidential, commercial infor3 mation) and shall request comments by interested persons 4 on the information contained in the application and on the 5 label, labeling, and advertising accompanying such appli6 cation. 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 ‘‘(f) ADVISORY COMMITTEE.— ‘‘(1) IN
GENERAL.—The

Secretary shall refer to

an advisory committee any application submitted under this subsection. ‘‘(2) RECOMMENDATIONS.—Not later than 60 days after the date an application is referred to an advisory committee under paragraph (1), the advisory committee shall report its recommendations on the application to the Secretary. ‘‘(g) APPROVAL.— ‘‘(1) MODIFIED
RISK PRODUCTS.—Except

as

provided in paragraph (2), the Secretary shall approve an application for a modified risk tobacco product filed under this section only if the Secretary determines that the applicant has demonstrated that such product, as it is actually used by consumers, will—

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88 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 ‘‘(A) significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and ‘‘(B) benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products. ‘‘(2) SPECIAL ‘‘(A) IN
RULE FOR CERTAIN PRODUCTS.— GENERAL.—The

Secretary may

approve an application for a tobacco product that has not been approved as a modified risk tobacco product pursuant to paragraph (1) if the Secretary makes the findings required under this paragraph and determines that the applicant has demonstrated that— ‘‘(i) the approval of the application would be appropriate to promote the public health; ‘‘(ii) any aspect of the label, labeling, and advertising for such product that would cause the tobacco product to be a modified risk tobacco product under subsection (b)(2) is limited to an explicit or implicit representation that such tobacco product or its smoke contains or is free of

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89 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 a substance or contains a reduced level of a substance, or presents a reduced exposure to a substance in tobacco smoke; ‘‘(iii) scientific evidence is not available and, using the best available scientific methods, cannot be made available without conducting long-term epidemiological studies for an application to meet the standards set forth in paragraph (1); and ‘‘(iv) the scientific evidence that is available without conducting long-term epidemiological studies demonstrates that a measurable and substantial reduction in morbidity or mortality among individual tobacco users is anticipated in subsequent studies. ‘‘(B) ADDITIONAL
FINDINGS REQUIRED.—

In order to approve an application under subparagraph (A) the Secretary must also find that the applicant has demonstrated that— ‘‘(i) the magnitude of the overall reductions in exposure to the substance or substances which are the subject of the application is substantial, such substance or substances are harmful, and the product as

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90 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 actually used exposes consumers to the specified reduced level of the substance or substances; ‘‘(ii) the product as actually used by consumers will not expose them to higher levels of other harmful substances compared to the similar types of tobacco products then on the market unless such increases are minimal and the anticipated overall impact of use of the product remains a substantial and measurable reduction in overall morbidity and mortality among individual tobacco users; ‘‘(iii) testing of actual consumer perception shows that, as the applicant proposes to label and market the product, consumers will not be misled into believing that the product— ‘‘(I) is or has been demonstrated to be less harmful; or ‘‘(II) presents or has been demonstrated to present less of a risk of disease than 1 or more other commercially marketed tobacco products; and

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91 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 ‘‘(iv) approval of the application is expected to benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products. ‘‘(C) CONDITIONS ‘‘(i) IN
OF APPROVAL.—

GENERAL.—Applications

ap-

proved under this paragraph shall be limited to a term of not more than 5 years, but may be renewed upon a finding by the Secretary that the requirements of this paragraph continue to be satisfied based on the filing of a new application. ‘‘(ii) AGREEMENTS
BY APPLICANT.—

Applications approved under this paragraph shall be conditioned on the applicant’s agreement to conduct postmarket surveillance and studies and to submit to the Secretary the results of such surveillance and studies to determine the impact of the application approval on consumer perception, behavior, and health and to enable the Secretary to review the accuracy of the determinations upon which the ap-

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92 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 proval was based in accordance with a protocol approved by the Secretary. ‘‘(iii) ANNUAL
SUBMISSION.—The

re-

sults of such postmarket surveillance and studies described in clause (ii) shall be submitted annually. ‘‘(3) BASIS.—The determinations under paragraphs (1) and (2) shall be based on— ‘‘(A) the scientific evidence submitted by the applicant; and ‘‘(B) scientific evidence and other information that is available to the Secretary. ‘‘(4) BENEFIT
TO HEALTH OF INDIVIDUALS

AND OF POPULATION AS A WHOLE.—In

making the

determinations under paragraphs (1) and (2), the Secretary shall take into account— ‘‘(A) the relative health risks to individuals of the tobacco product that is the subject of the application; ‘‘(B) the increased or decreased likelihood that existing users of tobacco products who would otherwise stop using such products will switch to the tobacco product that is the subject of the application;

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93 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 ‘‘(C) the increased or decreased likelihood that persons who do not use tobacco products will start using the tobacco product that is the subject of the application; ‘‘(D) the risks and benefits to persons from the use of the tobacco product that is the subject of the application as compared to the use of products for smoking cessation approved under chapter V to treat nicotine dependence; and ‘‘(E) comments, data, and information submitted by interested persons. ‘‘(h) ADDITIONAL CONDITIONS FOR APPROVAL.— ‘‘(1) MODIFIED
RISK PRODUCTS.—The

Sec-

retary shall require for the approval of an application under this section that any advertising or labeling concerning modified risk products enable the public to comprehend the information concerning modified risk and to understand the relative significance of such information in the context of total health and in relation to all of the diseases and health-related conditions associated with the use of tobacco products. ‘‘(2) COMPARATIVE
CLAIMS.—

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94 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 ‘‘(A) IN
GENERAL.—The

Secretary may re-

quire for the approval of an application under this subsection that a claim comparing a tobacco product to 1 or more other commercially marketed tobacco products shall compare the tobacco product to a commercially marketed tobacco product that is representative of that type of tobacco product on the market (for example the average value of the top 3 brands of an established regular tobacco product). ‘‘(B) QUANTITATIVE
COMPARISONS.—The

Secretary may also require, for purposes of subparagraph (A), that the percent (or fraction) of change and identity of the reference tobacco product and a quantitative comparison of the amount of the substance claimed to be reduced shall be stated in immediate proximity to the most prominent claim. ‘‘(3) LABEL ‘‘(A) IN
DISCLOSURE.— GENERAL.—The

Secretary may re-

quire the disclosure on the label of other substances in the tobacco product, or substances that may be produced by the consumption of that tobacco product, that may affect a disease or health-related condition or may increase the

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95 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 risk of other diseases or health-related conditions associated with the use of tobacco products. ‘‘(B) CONDITIONS
OF USE.—If

the condi-

tions of use of the tobacco product may affect the risk of the product to human health, the Secretary may require the labeling of conditions of use. ‘‘(4) TIME.—The Secretary shall limit an approval under subsection (g)(1) for a specified period of time. ‘‘(5) ADVERTISING.—The Secretary may require that an applicant, whose application has been approved under this subsection, comply with requirements relating to advertising and promotion of the tobacco product. ‘‘(i) POSTMARKET SURVEILLANCE ‘‘(1) IN
GENERAL.—The AND

STUDIES.—

Secretary shall require

that an applicant under subsection (g)(1) conduct postmarket surveillance and studies for a tobacco product for which an application has been approved to determine the impact of the application approval on consumer perception, behavior, and health, to enable the Secretary to review the accuracy of the determinations upon which the approval was based,

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96 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 and to provide information that the Secretary determines is otherwise necessary regarding the use or health risks involving the tobacco product. The results of postmarket surveillance and studies shall be submitted to the Secretary on an annual basis. ‘‘(2) SURVEILLANCE
PROTOCOL.—Each

appli-

cant required to conduct a surveillance of a tobacco product under paragraph (1) shall, within 30 days after receiving notice that the applicant is required to conduct such surveillance, submit, for the approval of the Secretary, a protocol for the required surveillance. The Secretary, within 60 days of the receipt of such protocol, shall determine if the principal investigator proposed to be used in the surveillance has sufficient qualifications and experience to conduct such surveillance and if such protocol will result in collection of the data or other information designated by the Secretary as necessary to protect the public health. ‘‘(j) WITHDRAWAL
OF

APPROVAL.—The Secretary,

21 after an opportunity for an informal hearing, shall with22 draw the approval of an application under this section if 23 the Secretary determines that— 24 25 ‘‘(1) the applicant, based on new information, can no longer make the demonstrations required

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97 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 under subsection (g), or the Secretary can no longer make the determinations required under subsection (g); ‘‘(2) the application failed to include material information or included any untrue statement of material fact; ‘‘(3) any explicit or implicit representation that the product reduces risk or exposure is no longer valid, including if— ‘‘(A) a tobacco product standard is established pursuant to section 907; ‘‘(B) an action is taken that affects the risks presented by other commercially marketed tobacco products that were compared to the product that is the subject of the application; or ‘‘(C) any postmarket surveillance or studies reveal that the approval of the application is no longer consistent with the protection of the public health; ‘‘(4) the applicant failed to conduct or submit the postmarket surveillance and studies required under subsection (g)(2)(C)(ii) or (i); or ‘‘(5) the applicant failed to meet a condition imposed under subsection (h).

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98 1 ‘‘(k) CHAPTER IV
OR

V.—A product approved in ac-

2 cordance with this section shall not be subject to chapter 3 IV or V. 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 ‘‘(l) IMPLEMENTING REGULATIONS ‘‘(1) SCIENTIFIC
OR

GUIDANCE.— later than 2

EVIDENCE.—Not

years after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, the Secretary shall issue regulations or guidance (or any combination thereof) on the scientific evidence required for assessment and ongoing review of modified risk tobacco products. Such regulations or guidance shall— ‘‘(A) establish minimum standards for scientific studies needed prior to approval to show that a substantial reduction in morbidity or mortality among individual tobacco users is likely; ‘‘(B) include validated biomarkers, intermediate clinical endpoints, and other feasible outcome measures, as appropriate; ‘‘(C) establish minimum standards for postmarket studies, that shall include regular and long-term assessments of health outcomes and mortality, intermediate clinical endpoints, consumer perception of harm reduction, and the

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99 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 impact on quitting behavior and new use of tobacco products, as appropriate; ‘‘(D) establish minimum standards for required postmarket surveillance, including ongoing assessments of consumer perception; and ‘‘(E) require that data from the required studies and surveillance be made available to the Secretary prior to the decision on renewal of a modified risk tobacco product. ‘‘(2) CONSULTATION.—The regulations or guidance issued under paragraph (1) shall be developed in consultation with the Institute of Medicine, and with the input of other appropriate scientific and medical experts, on the design and conduct of such studies and surveillance. ‘‘(3) REVISION.—The regulations or guidance under paragraph (1) shall be revised on a regular basis as new scientific information becomes available. ‘‘(4) NEW
TOBACCO PRODUCTS.—Not

later

than 2 years after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, the Secretary shall issue a regulation or guidance that permits the filing of a single application for any tobacco product that is a new tobacco prod-

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100 1 2 3 4 uct under section 910 and for which the applicant seeks approval as a modified risk tobacco product under this section. ‘‘(m) DISTRIBUTORS.—No distributor may take any

5 action, after the date of enactment of the Family Smoking 6 Prevention and Tobacco Control Act, with respect to a to7 bacco product that would reasonably be expected to result 8 in consumers believing that the tobacco product or its 9 smoke may present a lower risk of disease or is less harm10 ful than one or more commercially marketed tobacco prod11 ucts, or presents a reduced exposure to, or does not con12 tain or is free of, a substance or substances. 13 14 15 16 17 18 19 20 21 22 23 24 25
‘‘SEC. 912. JUDICIAL REVIEW.

‘‘(a) RIGHT TO REVIEW.— ‘‘(1) IN after— ‘‘(A) the promulgation of a regulation under section 907 establishing, amending, or revoking a tobacco product standard; or ‘‘(B) a denial of an application for approval under section 910(c), any person adversely affected by such regulation or denial may file a petition for judicial review of such regulation or denial with the United States Court of Appeals for the District of Columbia or for the cirGENERAL.—Not

later than 30 days

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101 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 cuit in which such person resides or has their principal place of business. ‘‘(2) REQUIREMENTS.— ‘‘(A) COPY
OF PETITION.—A

copy of the

petition filed under paragraph (1) shall be transmitted by the clerk of the court involved to the Secretary. ‘‘(B) RECORD
OF PROCEEDINGS.—On

re-

ceipt of a petition under subparagraph (A), the Secretary shall file in the court in which such petition was filed— ‘‘(i) the record of the proceedings on which the regulation or order was based; and ‘‘(ii) a statement of the reasons for the issuance of such a regulation or order. ‘‘(C) DEFINITION
OF RECORD.—In

this

section, the term ‘record’ means— ‘‘(i) all notices and other matter published in the Federal Register with respect to the regulation or order reviewed; ‘‘(ii) all information submitted to the Secretary with respect to such regulation or order;

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102 1 2 3 4 5 6 7 8 9 10 11 ‘‘(iii) proceedings of any panel or advisory committee with respect to such regulation or order; ‘‘(iv) any hearing held with respect to such regulation or order; and ‘‘(v) any other information identified by the Secretary, in the administrative proceeding held with respect to such regulation or order, as being relevant to such regulation or order. ‘‘(b) STANDARD
OF

REVIEW.—Upon the filing of the

12 petition under subsection (a) for judicial review of a regu13 lation or order, the court shall have jurisdiction to review 14 the regulation or order in accordance with chapter 7 of 15 title 5, United States Code, and to grant appropriate re16 lief, including interim relief, as provided for in such chap17 ter. A regulation or denial described in subsection (a) shall 18 be reviewed in accordance with section 706(2)(A) of title 19 5, United States Code. 20 ‘‘(c) FINALITY
OF

JUDGMENT.—The judgment of the

21 court affirming or setting aside, in whole or in part, any 22 regulation or order shall be final, subject to review by the 23 Supreme Court of the United States upon certiorari or 24 certification, as provided in section 1254 of title 28, 25 United States Code.

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103 1 ‘‘(d) OTHER REMEDIES.—The remedies provided for

2 in this section shall be in addition to, and not in lieu of, 3 any other remedies provided by law. 4 ‘‘(e) REGULATIONS
AND

ORDERS MUST RECITE

5 BASIS IN RECORD.—To facilitate judicial review, a regula6 tion or order issued under section 906, 907, 908, 909, 7 910, or 916 shall contain a statement of the reasons for 8 the issuance of such regulation or order in the record of 9 the proceedings held in connection with its issuance. 10 11
‘‘SEC. 913. EQUAL TREATMENT OF RETAIL OUTLETS.

‘‘The Secretary shall issue regulations to require that

12 retail establishments for which the predominant business 13 is the sale of tobacco products comply with any advertising 14 restrictions applicable to retail establishments accessible 15 to individuals under the age of 18. 16 17 18 19 20 21 22 23 24
‘‘SEC. 914. JURISDICTION OF AND COORDINATION WITH THE FEDERAL TRADE COMMISSION.

‘‘(a) JURISDICTION.— ‘‘(1) IN
GENERAL.—Except

where expressly

provided in this chapter, nothing in this chapter shall be construed as limiting or diminishing the authority of the Federal Trade Commission to enforce the laws under its jurisdiction with respect to the advertising, sale, or distribution of tobacco products.

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104 1 2 3 4 5 6 7 8 9 ‘‘(2) ENFORCEMENT.—Any advertising that violates this chapter or a provision of the regulations referred to in section 102 of the Family Smoking Prevention and Tobacco Control Act, is an unfair or deceptive act or practice under section 5(a) of the Federal Trade Commission Act (15 U.S.C. 45(a)) and shall be considered a violation of a rule promulgated under section 18 of that Act (15 U.S.C. 57a). ‘‘(b) COORDINATION.—With respect to the require-

10 ments of section 4 of the Federal Cigarette Labeling and 11 Advertising Act (15 U.S.C. 1333) and section 3 of the 12 Comprehensive Smokeless Tobacco Health Education Act 13 of 1986 (15 U.S.C. 4402)— 14 15 16 17 18 19 20 21 22 23 24 ‘‘(1) the Chairman of the Federal Trade Commission shall coordinate with the Secretary concerning the enforcement of such Act as such enforcement relates to unfair or deceptive acts or practices in the advertising of cigarettes or smokeless tobacco; and ‘‘(2) the Secretary shall consult with the Chairman of such Commission in revising the label statements and requirements under such sections.
‘‘SEC. 915. CONGRESSIONAL REVIEW PROVISIONS.

‘‘In accordance with section 801 of title 5, United

25 States Code, Congress shall review, and may disapprove,

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105 1 any rule under this chapter that is subject to section 801. 2 This section and section 801 do not apply to the regula3 tions referred to in section 102 of the Family Smoking 4 Prevention and Tobacco Control Act. 5 6
‘‘SEC. 916. REGULATION REQUIREMENT.

‘‘(a) TESTING, REPORTING,

AND

DISCLOSURE.—Not

7 later than 24 months after the date of enactment of the 8 Family Smoking Prevention and Tobacco Control Act, the 9 Secretary, acting through the Commissioner of the Food 10 and Drug Administration, shall promulgate regulations 11 under this Act that meet the requirements of subsection 12 (b). 13 ‘‘(b) CONTENTS
OF

RULES.—The regulations pro-

14 mulgated under subsection (a) shall require testing and 15 reporting of tobacco product constituents, ingredients, and 16 additives, including smoke constituents, by brand and sub17 brand that the Secretary determines should be tested to 18 protect the public health. The regulations may require 19 that tobacco product manufacturers, packagers, or import20 ers make disclosures relating to the results of the testing 21 of tar and nicotine through labels or advertising or other 22 appropriate means, and make disclosures regarding the re23 sults of the testing of other constituents, including smoke 24 constituents, ingredients, or additives, that the Secretary 25 determines should be disclosed to the public to protect the

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106 1 public health and will not mislead consumers about the 2 risk of tobacco related disease. 3 ‘‘(c) AUTHORITY.—The Food and Drug Administra-

4 tion shall have the authority under this chapter to conduct 5 or to require the testing, reporting, or disclosure of to6 bacco product constituents, including smoke constituents. 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
‘‘SEC. 917. PRESERVATION OF STATE AND LOCAL AUTHORITY.

‘‘(a) IN GENERAL.— ‘‘(1) PRESERVATION.—Nothing in this chapter, or rules promulgated under this chapter, shall be construed to limit the authority of a Federal agency (including the Armed Forces), a State or political subdivision of a State, or the government of an Indian tribe to enact, adopt, promulgate, and enforce any law, rule, regulation, or other measure with respect to tobacco products that is in addition to, or more stringent than, requirements established under this chapter, including a law, rule, regulation, or other measure relating to or prohibiting the sale, distribution, possession, exposure to, access to, advertising and promotion of, or use of tobacco products by individuals of any age, information reporting to the State, or measures relating to fire safety standards for tobacco products. No provision of this

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107 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 chapter shall limit or otherwise affect any State, Tribal, or local taxation of tobacco products. ‘‘(2) PREEMPTION
LOCAL REQUIREMENTS.— OF CERTAIN STATE AND

‘‘(A) IN

GENERAL.—Except

as provided in

paragraph (1) and subparagraph (B), no State or political subdivision of a State may establish or continue in effect with respect to a tobacco product any requirement which is different from, or in addition to, any requirement under the provisions of this chapter relating to tobacco product standards, premarket approval, adulteration, misbranding, labeling, registration, good manufacturing standards, or modified risk products. ‘‘(B) EXCEPTION.—Subparagraph (A)

does not apply to requirements relating to the sale, distribution, possession, information reporting to the State, exposure to, access to, the advertising and promotion of, or use of, tobacco products by individuals of any age, or relating to fire safety standards for tobacco products. Information disclosed to a State under subparagraph (A) that is exempt from disclosure under section 554(b)(4) of title 5, United States Code,

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108 1 2 3 shall be treated as trade secret and confidential information by the State. ‘‘(b) RULE OF CONSTRUCTION REGARDING PRODUCT

4 LIABILITY.—No provision of this chapter relating to a to5 bacco product shall be construed to modify or otherwise 6 affect any action or the liability of any person under the 7 product liability law of any State. 8 9 10
‘‘SEC. 918. TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE.

‘‘(a) ESTABLISHMENT.—Not later than 1 year after

11 the date of enactment of the Family Smoking Prevention 12 and Tobacco Control Act, the Secretary shall establish an 13 11-member advisory committee, to be known as the ‘To14 bacco Products Scientific Advisory Committee’. 15 16 17 18 19 20 21 22 23 24 25 ‘‘(b) MEMBERSHIP.— ‘‘(1) IN
GENERAL.—

‘‘(A) MEMBERS.—The Secretary shall appoint as members of the Tobacco Products Scientific Advisory Committee individuals who are technically qualified by training and experience in the medicine, medical ethics, science, or technology involving the manufacture, evaluation, or use of tobacco products, who are of appropriately diversified professional backgrounds. The committee shall be composed of—

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109 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 ‘‘(i) 7 individuals who are physicians, dentists, scientists, or health care professionals practicing in the area of oncology, pulmonology, cardiology, toxicology, pharmacology, addiction, or any other relevant specialty; ‘‘(ii) 1 individual who is an officer or employee of a State or local government or of the Federal Government; ‘‘(iii) 1 individual as a representative of the general public; ‘‘(iv) 1 individual as a representative of the interests in the tobacco manufacturing industry; and ‘‘(v) 1 individual as a representative of the interests of the tobacco growers. ‘‘(B) NONVOTING
MEMBERS.—The

mem-

bers of the committee appointed under clauses (iv) and (v) of subparagraph (A) shall serve as consultants to those described in clauses (i) through (iii) of subparagraph (A) and shall be nonvoting representatives. ‘‘(2) LIMITATION.—The Secretary may not appoint to the Advisory Committee any individual who is in the regular full-time employ of the Food and

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110 1 2 3 4 5 6 7 Drug Administration or any agency responsible for the enforcement of this Act. The Secretary may appoint Federal officials as ex officio members. ‘‘(3) CHAIRPERSON.—The Secretary shall designate 1 of the members of the Advisory Committee to serve as chairperson. ‘‘(c) DUTIES.—The Tobacco Products Scientific Ad-

8 visory Committee shall provide advice, information, and 9 recommendations to the Secretary— 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 ‘‘(1) as provided in this chapter; ‘‘(2) on the effects of the alteration of the nicotine yields from tobacco products; ‘‘(3) on whether there is a threshold level below which nicotine yields do not produce dependence on the tobacco product involved; and ‘‘(4) on its review of other safety, dependence, or health issues relating to tobacco products as requested by the Secretary. ‘‘(d) COMPENSATION; SUPPORT; FACA.— ‘‘(1) COMPENSATION
AND TRAVEL.—Members

of the Advisory Committee who are not officers or employees of the United States, while attending conferences or meetings of the committee or otherwise engaged in its business, shall be entitled to receive compensation at rates to be fixed by the Secretary,

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111 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 which may not exceed the daily equivalent of the rate in effect for level 4 of the Senior Executive Schedule under section 5382 of title 5, United States Code, for each day (including travel time) they are so engaged; and while so serving away from their homes or regular places of business each member may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by section 5703 of title 5, United States Code, for persons in the Government service employed intermittently. ‘‘(2) ADMINISTRATIVE
SUPPORT.—The

Sec-

retary shall furnish the Advisory Committee clerical and other assistance. ‘‘(3) NONAPPLICATION
OF FACA.—Section

14 of

the Federal Advisory Committee Act (5 U.S.C. App.) does not apply to the Advisory Committee. ‘‘(e) PROCEEDINGS
MITTEES.—The OF

ADVISORY PANELS

AND

COM-

Advisory Committee shall make and

19 maintain a transcript of any proceeding of the panel or 20 committee. Each such panel and committee shall delete 21 from any transcript made under this subsection informa22 tion which is exempt from disclosure under section 552(b) 23 of title 5, United States Code.

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112 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
‘‘SEC. 919. DRUG PRODUCTS USED TO TREAT TOBACCO DEPENDENCE.

‘‘The Secretary shall— ‘‘(1) at the request of the applicant, consider designating nicotine replacement products as fast track research and approval products within the meaning of section 506; ‘‘(2) direct the Commissioner to consider approving the extended use of nicotine replacement products (such as nicotine patches, nicotine gum, and nicotine lozenges) for the treatment of tobacco dependence; ‘‘(3) review and consider the evidence for additional indications for nicotine replacement products, such as for craving relief or relapse prevention; and ‘‘(4) consider— ‘‘(A) relieving companies of premarket burdens under section 505 if the requirement is redundant considering other nicotine replacement therapies already on the market; and ‘‘(B) time and extent applications for nicotine replacement therapies that have been approved by a regulatory body in a foreign country and have marketing experience in such country.

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113 1 2
‘‘SEC. 920. USER FEE.

‘‘(a) ESTABLISHMENT

OF

QUARTERLY USER FEE.—

3 The Secretary shall assess a quarterly user fee with re4 spect to every quarter of each fiscal year commencing fis5 cal year 2004, calculated in accordance with this section, 6 upon each manufacturer and importer of tobacco products 7 subject to this chapter. 8 ‘‘(b) FUNDING
OF

FDA REGULATION

OF

TOBACCO

9 PRODUCTS.—The Secretary shall make user fees collected 10 pursuant to this section available to pay, in each fiscal 11 year, for the costs of the activities of the Food and Drug 12 Administration related to the regulation of tobacco prod13 ucts under this chapter. 14 15 16 17 18 19 20 21 22 23 24 25 26 ‘‘(c) ASSESSMENT OF USER FEE.— ‘‘(1) AMOUNT
OF ASSESSMENT.—Except

as

provided in paragraph (4), the total user fees assessed each year pursuant to this section shall be sufficient, and shall not exceed what is necessary, to pay for the costs of the activities described in subsection (b) for each fiscal year. ‘‘(2) ALLOCATION
OF ASSESSMENT BY CLASS

OF TOBACCO PRODUCTS.—

‘‘(A) IN

GENERAL.—Subject

to paragraph

(3), the total user fees assessed each fiscal year with respect to each class of importers and manufacturers shall be equal to an amount that
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114 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 is the applicable percentage of the total costs of activities of the Food and Drug Administration described in subsection (b). ‘‘(B) APPLICABLE
PERCENTAGE.—For

purposes of subparagraph (A) the applicable percentage for a fiscal year shall be the following: ‘‘(i) 92.07 percent shall be assessed on manufacturers and importers of cigarettes; ‘‘(ii) 0.05 percent shall be assessed on manufacturers and importers of little cigars; ‘‘(iii) 7.15 percent shall be assessed on manufacturers and importers of cigars other than little cigars; ‘‘(iv) 0.43 percent shall be assessed on manufacturers and importers of snuff; ‘‘(v) 0.10 percent shall be assessed on manufacturers and importers of chewing tobacco; ‘‘(vi) 0.06 percent shall be assessed on manufacturers and importers of pipe tobacco; and

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115 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 ‘‘(vii) 0.14 percent shall be assessed on manufacturers and importers of rollyour-own tobacco. ‘‘(3) DISTRIBUTION
OF FEE SHARES OF MANU-

FACTURERS AND IMPORTERS EXEMPT FROM USER FEE.—Where

a class of tobacco products is not sub-

ject to a user fee under this section, the portion of the user fee assigned to such class under subsection (d)(2) shall be allocated by the Secretary on a pro rata basis among the classes of tobacco products that are subject to a user fee under this section. Such pro rata allocation for each class of tobacco products that are subject to a user fee under this section shall be the quotient of— ‘‘(A) the sum of the percentages assigned to all classes of tobacco products subject to this section; divided by ‘‘(B) the percentage assigned to such class under paragraph (2). ‘‘(4) ANNUAL
LIMIT ON ASSESSMENT.—The

total assessment under this section— ‘‘(A) for fiscal year 2004 shall be

$85,000,000; ‘‘(B) for fiscal year 2005 shall be

$175,000,000;

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116 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 ‘‘(C) for fiscal year 2006 shall be

$300,000,000; and ‘‘(D) for each subsequent fiscal year, shall not exceed the limit on the assessment imposed during the previous fiscal year, as adjusted by the Secretary (after notice, published in the Federal Register) to reflect the greater of— ‘‘(i) the total percentage change that occurred in the Consumer Price Index for all urban consumers (all items; United States city average) for the 12-month period ending on June 30 of the preceding fiscal year for which fees are being established; or ‘‘(ii) the total percentage change for the previous fiscal year in basic pay under the General Schedule in accordance with section 5332 of title 5, United States Code, as adjusted by any locality-based comparability payment pursuant to section 5304 of such title for Federal employees stationed in the District of Columbia. ‘‘(5) TIMING
OF USER FEE ASSESSMENT.—The

Secretary shall notify each manufacturer and importer of tobacco products subject to this section of

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117 1 2 3 4 5 6 7 8 9 the amount of the quarterly assessment imposed on such manufacturer or importer under subsection (f) during each quarter of each fiscal year. Such notifications shall occur not earlier than 3 months prior to the end of the quarter for which such assessment is made, and payments of all assessments shall be made not later than 60 days after each such notification. ‘‘(d) DETERMINATION
OF

USER FEE

BY

COMPANY

10 MARKET SHARE.— 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 ‘‘(1) IN
GENERAL.—The

user fee to be paid by

each manufacturer or importer of a given class of tobacco products shall be determined in each quarter by multiplying— ‘‘(A) such manufacturer’s or importer’s market share of such class of tobacco products; by ‘‘(B) the portion of the user fee amount for the current quarter to be assessed on manufacturers and importers of such class of tobacco products as determined under subsection (e). ‘‘(2) NO
FEE IN EXCESS OF MARKET SHARE.—

No manufacturer or importer of tobacco products shall be required to pay a user fee in excess of the market share of such manufacturer or importer.

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118 1 ‘‘(e) DETERMINATION
OF

VOLUME

OF

DOMESTIC

2 SALES.— 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 ‘‘(1) IN
GENERAL.—The

calculation of gross

domestic volume of a class of tobacco product by a manufacturer or importer, and by all manufacturers and importers as a group, shall be made by the Secretary using information provided by manufacturers and importers pursuant to subsection (f), as well as any other relevant information provided to or obtained by the Secretary. ‘‘(2) MEASUREMENT.—For purposes of the calculations under this subsection and the information provided under subsection (f) by the Secretary, gross domestic volume shall be measured by— ‘‘(A) in the case of cigarettes, the number of cigarettes sold; ‘‘(B) in the case of little cigars, the number of little cigars sold; ‘‘(C) in the case of large cigars, the number of cigars weighing more than 3 pounds per thousand sold; and ‘‘(D) in the case of other classes of tobacco products, in terms of number of pounds, or fraction thereof, of these products sold.

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119 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 ‘‘(f) MEASUREMENT
UME.— OF

GROSS DOMESTIC VOL-

‘‘(1) IN

GENERAL.—Each

manufacturer and

importer of tobacco products shall submit to the Secretary a certified copy of each of the returns or forms described by this paragraph that are required to be filed with a Government agency on the same date that those returns or forms are filed, or required to be filed, with such agency. The returns and forms described by this paragraph are those returns and forms related to the release of tobacco products into domestic commerce, as defined by section 5702(k) of the Internal Revenue Code of 1986, and the repayment of the taxes imposed under chapter 52 of such Code (ATF Form 500.24 and United States Customs Form 7501 under currently applicable regulations). ‘‘(2) PENALTIES.—Any person that knowingly fails to provide information required under this subsection or that provides false information under this subsection shall be subject to the penalties described in section 1003 of title 18, United States Code. In addition, such person may be subject to a civil penalty in an amount not to exceed 2 percent of the value of the kind of tobacco products manufactured

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120 1 2 3 or imported by such person during the applicable quarter, as determined by the Secretary. ‘‘(g) EFFECTIVE DATE.—The user fees prescribed by

4 this section shall be assessed in fiscal year 2004, based 5 on domestic sales of tobacco products during fiscal year 6 2003 and shall be assessed in each fiscal year thereafter.’’. 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
SEC. 102. INTERIM FINAL RULE.

(a) CIGARETTES AND SMOKELESS TOBACCO.— (1) IN
GENERAL.—Not

later than 30 days after

the date of enactment of this Act, the Secretary of Health and Human Services shall publish in the Federal Register an interim final rule regarding cigarettes and smokeless tobacco, which is hereby deemed to be in compliance with the Administrative Procedures Act and other applicable law. (2) CONTENTS
OF RULE.—Except

as provided

in this subsection, the interim final rule published under paragraph (1), shall be identical in its provisions to part 897 of the regulations promulgated by the Secretary of Health and Human Services in the August 28, 1996, issue of the Federal Register (61 Fed. Reg., 44615–44618). Such rule shall— (A) provide for the designation of jurisdictional authority that is in accordance with this subsection;

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121 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 (B) strike Subpart C—Labeling and section 897.32(c); and (C) become effective not later than 1 year after the date of enactment of this Act. (3) AMENDMENTS
TO RULE.—Prior

to making

amendments to the rule published under paragraph (1), the Secretary shall promulgate a proposed rule in accordance with the Administrative Procedures Act. (4) RULE
OF CONSTRUCTION.—Except

as pro-

vided in paragraph (3), nothing in this section shall be construed to limit the authority of the Secretary to amend, in accordance with the Administrative Procedures Act, the regulation promulgated pursuant to this section. (b) LIMITATION
ON

ADVISORY OPINIONS.—As of the

17 date of enactment of this Act, the following documents 18 issued by the Food and Drug Administration shall not 19 constitute advisory opinions under section 10.85(d)(1) of 20 title 21, Code of Federal Regulations, except as they apply 21 to tobacco products, and shall not be cited by the Sec22 retary of Health and Human Services or the Food and 23 Drug Administration as binding precedent: 24 25 (1) The preamble to the proposed rule in the document entitled ‘‘Regulations Restricting the Sale

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122 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 and Distribution of Cigarettes and Smokeless Tobacco Products to Protect Children and Adolescents’’ (60 Fed. Reg. 41314–41372 (August 11, 1995)). (2) The document entitled ‘‘Nicotine in Cigarettes and Smokeless Tobacco Products is a Drug and These Products Are Nicotine Delivery Devices Under the Federal Food, Drug, and Cosmetic Act’’ (60 Fed. Reg. 41453–41787 (August 11, 1995)). (3) The preamble to the final rule in the document entitled ‘‘Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents’’ (61 Fed. Reg. 44396–44615 (August 28, 1996)). (4) The document entitled ‘‘Nicotine in Cigarettes and Smokeless Tobacco is a Drug and These Products are Nicotine Delivery Devices Under the Federal Food, Drug, and Cosmetic Act; Jurisdictional Determination’’ (61 Fed. Reg. 44619–45318 (August 28, 1996)).
SEC. 103. CONFORMING AND OTHER AMENDMENTS TO GENERAL PROVISIONS.

(a) AMENDMENT

OF

FEDERAL FOOD, DRUG,

AND

24 COSMETIC ACT.—Except as otherwise expressly provided, 25 whenever in this section an amendment is expressed in

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123 1 terms of an amendment to, or repeal of, a section or other 2 provision, the reference is to a section or other provision 3 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 4 301 et seq.). 5 (b) SECTION 301.—Section 301 (21 U.S.C. 331) is

6 amended— 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 (1) in subsection (a), by inserting ‘‘tobacco product,’’ after ‘‘device,’’; (2) in subsection (b), by inserting ‘‘tobacco product,’’ after ‘‘device,’’; (3) in subsection (c), by inserting ‘‘tobacco product,’’ after ‘‘device,’’; (4) in subsection (e), by striking ‘‘515(f), or 519’’ and inserting ‘‘515(f), 519, or 909’’; (5) in subsection (g), by inserting ‘‘tobacco product,’’ after ‘‘device,’’; (6) in subsection (h), by inserting ‘‘tobacco product,’’ after ‘‘device,’’; (7) in subsection (j), by striking ‘‘708, or 721’’ and inserting ‘‘708, 721, 904, 905, 906, 907, 908, 909, or section 921(b)’’; (8) in subsection (k), by inserting ‘‘tobacco product,’’ after ‘‘device,’’; (9) by striking subsection (p) and inserting the following:

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124 1 ‘‘(p) The failure to register in accordance with section

2 510 or 905, the failure to provide any information re3 quired by section 510(j), 510(k), 905(i), or 905(j), or the 4 failure to provide a notice required by section 510(j)(2) 5 or 905(i)(2).’’; 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 (10) by striking subsection (q)(1) and inserting the following: ‘‘(q)(1) The failure or refusal— ‘‘(A) to comply with any requirement prescribed under section 518, 520(g), 903(b)(8), or 908, or condition prescribed under section

903(b)(6)(B)(ii)(II); ‘‘(B) to furnish any notification or other material or information required by or under section 519, 520(g), 904, 909, or section 921; or ‘‘(C) to comply with a requirement under section 522 or 913.’’; (11) in subsection (q)(2), by striking ‘‘device,’’ and inserting ‘‘device or tobacco product,’’; (12) in subsection (r), by inserting ‘‘or tobacco product’’ after ‘‘device’’ each time that it appears; and (13) by adding at the end the following:

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125 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 ‘‘(aa) The sale of tobacco products in violation of a no-tobacco-sale order issued under section 303(f). ‘‘(bb) The introduction or delivery for introduction into interstate commerce of a tobacco product in violation of section 911. ‘‘(cc)(1) Forging, counterfeiting, simulating, or falsely representing, or without proper authority using any mark, stamp (including tax stamp), tag, label, or other identification device upon any tobacco product or container or labeling thereof so as to render such tobacco product a counterfeit tobacco product. ‘‘(2) Making, selling, disposing of, or keeping in possession, control, or custody, or concealing any punch, die, plate, stone, or other item that is designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark, imprint, or device of another or any likeness of any of the foregoing upon any tobacco product or container or labeling thereof so as to render such tobacco product a counterfeit tobacco product. ‘‘(3) The doing of any act that causes a tobacco product to be a counterfeit tobacco product, or the

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126 1 2 3 4 5 6 7 8 sale or dispensing, or the holding for sale or dispensing, of a counterfeit tobacco product. ‘‘(dd) The charitable distribution of tobacco products. ‘‘(ee) The failure of a manufacturer or distributor to notify the Attorney General of their knowledge of tobacco products used in illicit trade.’’. (c) SECTION 303.—Section 303 (21 U.S.C. 333(f))

9 is amended in subsection (f)— 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 (1) by striking the subsection heading and inserting the following: ‘‘(f) CIVIL PENALTIES; NO-TOBACCO-SALE ORDERS.—’’;

(2) in paragraph (1)(A), by inserting ‘‘or tobacco products’’ after ‘‘devices’’; (3) by redesignating paragraphs (3), (4), and (5) as paragraphs (4), (5), and (6), and inserting after paragraph (2) the following: ‘‘(3) If the Secretary finds that a person has committed repeated violations of restrictions promulgated under section 906(d) at a particular retail outlet then the Secretary may impose a no-tobacco-sale order on that person prohibiting the sale of tobacco products in that outlet. A no-tobacco-sale order may

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127 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 be imposed with a civil penalty under paragraph (1).’’; (4) in paragraph (4) as so redesignated— (A) in subparagraph (A)— (i) by striking ‘‘assessed’’ the first time it appears and inserting ‘‘assessed, or a no-tobacco-sale order may be imposed,’’; and (ii) by striking ‘‘penalty’’ and inserting ‘‘penalty, or upon whom a no-tobaccoorder is to be imposed,’’; (B) in subparagraph (B)— (i) by inserting after ‘‘penalty,’’ the following: ‘‘or the period to be covered by a no-tobacco-sale order,’’; and (ii) by adding at the end the following: ‘‘A no-tobacco-sale order permanently prohibiting an individual retail outlet from selling tobacco products shall include provisions that allow the outlet, after a specified period of time, to request that the Secretary compromise, modify, or terminate the order.’’; and (C) by adding at the end, the following:

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128 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 ‘‘(D) The Secretary may compromise, modify, or terminate, with or without conditions, any no-tobacco-sale order.’’; (5) in paragraph (5) as so redesignated— (A) by striking ‘‘(3)(A)’’ as redesignated, and inserting ‘‘(4)(A)’’; (B) by inserting ‘‘or the imposition of a no-tobacco-sale order’’ after ‘‘penalty’’ the first 2 places it appears; and (C) by striking ‘‘issued.’’ and inserting ‘‘issued, or on which the no-tobacco-sale order was imposed, as the case may be.’’; and (6) in paragraph (6), as so redesignated, by striking ‘‘paragraph (4)’’ each place it appears and inserting ‘‘paragraph (5)’’. (d) SECTION 304.—Section 304 (21 U.S.C. 334) is

17 amended— 18 19 20 21 22 23 24 (1) in subsection (a)(2)— (A) by striking ‘‘and’’ before ‘‘(D)’’; and (B) by striking ‘‘device.’’ and inserting the following: ‘‘, (E) Any adulterated or misbranded tobacco product.’’; (2) in subsection (d)(1), by inserting ‘‘tobacco product,’’ after ‘‘device,’’;

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129 1 2 3 4 5 6 (3) in subsection (g)(1), by inserting ‘‘or tobacco product’’ after ‘‘device’’ each place it appears; and (4) in subsection (g)(2)(A), by inserting ‘‘or tobacco product’’ after ‘‘device’’ each place it appears. (e) SECTION 702.—Section 702(a) (21 U.S.C.

7 372(a)) is amended— 8 9 10 (1) by inserting ‘‘(1)’’ after ‘‘(a)’’; and (2) by adding at the end thereof the following: ‘‘(2) For a tobacco product, to the extent feasible,

11 the Secretary shall contract with the States in accordance 12 with paragraph (1) to carry out inspections of retailers 13 in connection with the enforcement of this Act.’’. 14 (f) SECTION 703.—Section 703 (21 U.S.C. 373) is

15 amended— 16 17 18 19 20 (1) by inserting ‘‘tobacco product,’’ after ‘‘device,’’ each place it appears; and (2) by inserting ‘‘tobacco products,’’ after ‘‘devices,’’ each place it appears. (g) SECTION 704.—Section 704 (21 U.S.C. 374) is

21 amended— 22 23 24 (1) in subsection (a)(1)(A), by inserting ‘‘tobacco products,’’ after ‘‘devices,’’ each place it appears;

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130 1 2 3 4 5 6 (2) in subsection (a)(1)(B), by inserting ‘‘or tobacco product’’ after ‘‘restricted devices’’ each place it appears; and (3) in subsection (b), by inserting ‘‘tobacco product,’’ after ‘‘device,’’. (h) SECTION 705.—Section 705(b) (21 U.S.C.

7 375(b)) is amended by inserting ‘‘tobacco products,’’ after 8 ‘‘devices,’’. 9 (i) SECTION 709.—Section 709 (21 U.S.C. 379) is

10 amended by inserting ‘‘or tobacco product’’ after ‘‘device’’. 11 (j) SECTION 801.—Section 801 (21 U.S.C. 381) is

12 amended— 13 14 15 16 17 18 19 20 21 22 23 24 (1) in subsection (a)— (A) by inserting ‘‘tobacco products,’’ after ‘‘devices,’’ the first time it appears; (B) by inserting ‘‘or section 905(j)’’ after ‘‘section 510’’; and (C) by striking ‘‘drugs or devices’’ each time it appears and inserting ‘‘drugs, devices, or tobacco products’’; (2) in subsection (e)(1), by inserting ‘‘tobacco product,’’ after ‘‘device,’’; and (3) by adding at the end the following: ‘‘(p)(1) Not later than 2 years after the date of enact-

25 ment of the Family Smoking Prevention and Tobacco

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131 1 Control Act, and annually thereafter, the Secretary shall 2 submit to the Committee on Health, Education, Labor, 3 and Pensions of the Senate and the Committee on Energy 4 and Commerce of the House of Representatives, a report 5 regarding— 6 7 8 9 10 11 12 13 14 15 16 17 ‘‘(A) the nature, extent, and destination of United States tobacco product exports that do not conform to tobacco product standards established pursuant to this Act; ‘‘(B) the public health implications of such exports, including any evidence of a negative public health impact; and ‘‘(C) recommendations or assessments of policy alternatives available to Congress and the Executive Branch to reduce any negative public health impact caused by such exports. ‘‘(2) The Secretary is authorized to establish appro-

18 priate information disclosure requirements to carry out 19 this subsection.’’. 20 (k) SECTION 1003.—Section 1003(d)(2)(C) (as re-

21 designated by section 101(a)) is amended— 22 23 24 (1) by striking ‘‘and’’ after ‘‘cosmetics,’’; and (2) inserting a comma and ‘‘and tobacco products’’ after ‘‘devices’’.

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132 1 (l) EFFECTIVE DATE
FOR

NO-TOBACCO-SALE

2 ORDER AMENDMENTS.—The amendments made by sub3 section (c), other than the amendment made by paragraph 4 (2) of such subsection, shall take effect upon the issuance 5 of guidance by the Secretary of Health and Human Serv6 ices— 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 (1) defining the term ‘‘repeated violation’’, as used in section 303(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)) as amended by subsection (c), by identifying the number of violations of particular requirements over a specified period of time at a particular retail outlet that constitute a repeated violation; (2) providing for timely and effective notice to the retailer of each alleged violation at a particular retail outlet and an expedited procedure for the administrative appeal of an alleged violation; (3) providing that a person may not be charged with a violation at a particular retail outlet unless the Secretary has provided notice to the retailer of all previous violations at that outlet; (4) establishing a period of time during which, if there are no violations by a particular retail outlet, that outlet will not considered to have been the

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133 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 site of repeated violations when the next violation occurs; and (5) providing that good faith reliance on the presentation of a false government issued photographic identification that contains the bearer’s date of birth does not constitute a violation of any minimum age requirement for the sale of tobacco products if the retailer has taken effective steps to prevent such violations, including— (A) adopting and enforcing a written policy against sales to minors; (B) informing its employees of all applicable laws; (C) establishing disciplinary sanctions for employee noncompliance; and (D) requiring its employees to verify age by way of photographic identification or electronic scanning device.

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134 1 2 3 4 5 6

TITLE II—TOBACCO PRODUCT WARNINGS; CONSTITUENT AND SMOKE CONSTITUENT DISCLOSURE
SEC. 201. CIGARETTE LABEL AND ADVERTISING WARNINGS.

Section 4 of the Federal Cigarette Labeling and Ad-

7 vertising Act (15 U.S.C. 1333) is amended to read as fol8 lows: 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
‘‘SEC. 4. LABELING.

‘‘(a) LABEL REQUIREMENTS.— ‘‘(1) IN
GENERAL.—It

shall be unlawful for any

person to manufacture, package, sell, offer to sell, distribute, or import for sale or distribution within the United States any cigarettes the package of which fails to bear, in accordance with the requirements of this section, one of the following labels: ‘WARNING: Cigarettes are addictive’. ‘WARNING: Tobacco smoke can harm your children’. ‘WARNING: Cigarettes cause fatal lung disease’. ‘WARNING: Cigarettes cause cancer’. ‘WARNING: Cigarettes cause strokes and heart disease’. ‘WARNING: Smoking during pregnancy can harm your baby’.
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135 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 ‘WARNING: Smoking can kill you’. ‘WARNING: Tobacco smoke causes fatal lung disease in non-smokers’. ‘WARNING: Quitting smoking now greatly reduces serious risks to your health’. ‘‘(2) PLACEMENT; ‘‘(A) IN
TYPOGRAPHY; ETC.—

GENERAL.—Each

label statement

required by paragraph (1) shall be located in the upper portion of the front and rear panels of the package, directly on the package underneath the cellophane or other clear wrapping. Except as provided in subparagraph (B), each label statement shall comprise at least the top 30 percent of the front and rear panels of the package. The word ‘WARNING’ shall appear in capital letters and all text shall be in conspicuous and legible 17-point type, unless the text of the label statement would occupy more than 70 percent of such area, in which case the text may be in a smaller conspicuous and legible type size, provided that at least 60 percent of such area is occupied by required text. The text shall be black on a white background, or white on a black background, in a manner that contrasts, by typography, layout, or color, with

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136 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 all other printed material on the package, in an alternating fashion under the plan submitted under subsection (b)(4). ‘‘(B) FLIP-TOP
BOXES.—For

any cigarette

brand package manufactured or distributed before January 1, 2000, which employs a flip-top style (if such packaging was used for that brand in commerce prior to June 21, 1997), the label statement required by paragraph (1) shall be located on the flip-top area of the package, even if such area is less than 25 percent of the area of the front panel. Except as provided in this paragraph, the provisions of this subsection shall apply to such packages. ‘‘(3) DOES
TION.—The NOT APPLY TO FOREIGN DISTRIBU-

provisions of this subsection do not

apply to a tobacco product manufacturer or distributor of cigarettes which does not manufacture, package, or import cigarettes for sale or distribution within the United States. ‘‘(4) APPLICABILITY
TO RETAILERS.—A

retailer

of cigarettes shall not be in violation of this subsection for packaging that is supplied to the retailer by a tobacco product manufacturer, importer, or distributor and is not altered by the retailer in a way

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137 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 that is material to the requirements of this subsection except that this paragraph shall not relieve a retailer of liability if the retailer sells or distributes tobacco products that are not labeled in accordance with this subsection. ‘‘(b) ADVERTISING REQUIREMENTS.— ‘‘(1) IN
GENERAL.—It

shall be unlawful for any

tobacco product manufacturer, importer, distributor, or retailer of cigarettes to advertise or cause to be advertised within the United States any cigarette unless its advertising bears, in accordance with the requirements of this section, one of the labels specified in subsection (a) of this section. ‘‘(2) TYPOGRAPHY,
ETC.—Each

label statement

required by subsection (a) of this section in cigarette advertising shall comply with the standards set forth in this paragraph. For press and poster advertisements, each such statement and (where applicable) any required statement relating to tar, nicotine, or other constituent (including a smoke constituent) yield shall comprise at least 20 percent of the area of the advertisement and shall appear in a conspicuous and prominent format and location at the top of each advertisement within the trim area. The Secretary may revise the required type sizes in such

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138 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 area in such manner as the Secretary determines appropriate. The word ‘WARNING’ shall appear in capital letters, and each label statement shall appear in conspicuous and legible type. The text of the label statement shall be black if the background is white and white if the background is black, under the plan submitted under paragraph (4) of this subsection. The label statements shall be enclosed by a rectangular border that is the same color as the letters of the statements and that is the width of the first downstroke of the capital ‘W’ of the word ‘WARNING’ in the label statements. The text of such label statements shall be in a typeface pro rata to the following requirements: 45-point type for a whole-page broadsheet newspaper advertisement; 39-point type for a half-page broadsheet newspaper advertisement; 39-point type for a whole-page tabloid newspaper advertisement; 27-point type for a half-page tabloid newspaper advertisement; 31.5-point type for a double page spread magazine or whole-page magazine advertisement; 22.5-point type for a 28 centimeter by 3 column advertisement; and 15-point type for a 20 centimeter by 2 column advertisement. The label statements shall be in English, except that in the case of—

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139 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 ‘‘(A) an advertisement that appears in a newspaper, magazine, periodical, or other publication that is not in English, the statements shall appear in the predominant language of the publication; and ‘‘(B) in the case of any other advertisement that is not in English, the statements shall appear in the same language as that principally used in the advertisement. ‘‘(3) MATCHBOOKS.—Notwithstanding para-

graph (2), for matchbooks (defined as containing not more than 20 matches) customarily given away with the purchase of tobacco products, each label statement required by subsection (a) may be printed on the inside cover of the matchbook. ‘‘(4) ADJUSTMENT
BY SECRETARY.—The

Sec-

retary may, through a rulemaking under section 553 of title 5, United States Code, adjust the format and type sizes for the label statements required by this section or the text, format, and type sizes of any required tar, nicotine yield, or other constituent (including smoke constituent) disclosures, or to establish the text, format, and type sizes for any other disclosures required under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). The text

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140 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 of any such label statements or disclosures shall be required to appear only within the 20 percent area of cigarette advertisements provided by paragraph (2) of this subsection. The Secretary shall promulgate regulations which provide for adjustments in the format and type sizes of any text required to appear in such area to ensure that the total text required to appear by law will fit within such area. ‘‘(5) MARKETING
REQUIREMENTS.—

‘‘(A) The label statements specified in subsection (a)(1) shall be randomly displayed in each 12-month period, in as equal a number of times as is possible on each brand of the product and be randomly distributed in all areas of the United States in which the product is marketed in accordance with a plan submitted by the tobacco product manufacturer, importer, distributor, or retailer and approved by the Secretary. ‘‘(B) The label statements specified in subsection (a)(1) shall be rotated quarterly in alternating sequence in advertisements for each brand of cigarettes in accordance with a plan submitted by the tobacco product manufacturer,

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141 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 importer, distributor, or retailer to, and approved by, the Secretary. ‘‘(C) The Secretary shall review each plan submitted under subparagraph (B) and approve it if the plan— ‘‘(i) will provide for the equal distribution and display on packaging and the rotation required in advertising under this subsection; and ‘‘(ii) assures that all of the labels required under this section will be displayed by the tobacco product manufacturer, importer, distributor, or retailer at the same time. ‘‘(6) APPLICABILITY
TO RETAILERS.—This

sub-

section applies to a retailer only if that retailer is responsible for or directs the label statements required under this section except that this paragraph shall not relieve a retailer of liability if the retailer displays, in a location open to the public, an advertisement that is not labeled in accordance with the requirements of this subsection.’’.

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142 1 2 3
SEC. 202. AUTHORITY TO REVISE CIGARETTE WARNING LABEL STATEMENTS.

Section 4 of the Federal Cigarette Labeling and Ad-

4 vertising Act (15 U.S.C. 1333), as amended by section 5 201, is further amended by adding at the end the fol6 lowing: 7 ‘‘(c) CHANGE IN REQUIRED STATEMENTS.—The Sec-

8 retary may, by a rulemaking conducted under section 553 9 of title 5, United States Code, adjust the format, type size, 10 and text of any of the label requirements, require color 11 graphics to accompany the text, increase the required label 12 area from 30 percent up to 50 percent of the front and 13 rear panels of the package, or establish the format, type 14 size, and text of any other disclosures required under the 15 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 16 et seq.), if the Secretary finds that such a change would 17 promote greater public understanding of the risks associ18 ated with the use of tobacco products.’’. 19 20 21
SEC. 203. STATE REGULATION OF CIGARETTE ADVERTISING AND PROMOTION.

Section 5 of the Federal Cigarette Labeling and Ad-

22 vertising Act (15 U.S.C. 1334) is amended by adding at 23 the end the following: 24 ‘‘(c) EXCEPTION.—Notwithstanding subsection (b), a

25 State or locality may enact statutes and promulgate regu26 lations, based on smoking and health, that take effect
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143 1 after the effective date of the Family Smoking Prevention 2 and Tobacco Control Act, imposing specific bans or re3 strictions on the time, place, and manner, but not content, 4 of the advertising or promotion of any cigarettes.’’. 5 6 7
SEC. 204. SMOKELESS TOBACCO LABELS AND ADVERTISING WARNINGS.

Section 3 of the Comprehensive Smokeless Tobacco

8 Health Education Act of 1986 (15 U.S.C. 4402) is amend9 ed to read as follows: 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
‘‘SEC. 3. SMOKELESS TOBACCO WARNING.

‘‘(a) GENERAL RULE.— ‘‘(1) It shall be unlawful for any person to manufacture, package, sell, offer to sell, distribute, or import for sale or distribution within the United States any smokeless tobacco product unless the product package bears, in accordance with the requirements of this Act, one of the following labels: ‘WARNING: This product can cause mouth cancer’. ‘WARNING: This product can cause gum disease and tooth loss’. ‘WARNING: This product is not a safe alternative to cigarettes’. ‘WARNING: Smokeless tobacco is addictive’. ‘‘(2) Each label statement required by paragraph (1) shall be—

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144 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 ‘‘(A) located on the 2 principal display panels of the package, and each label statement shall comprise at least 30 percent of each such display panel; and ‘‘(B) in 17-point conspicuous and legible type and in black text on a white background, or white text on a black background, in a manner that contrasts by typography, layout, or color, with all other printed material on the package, in an alternating fashion under the plan submitted under subsection (b)(3), except that if the text of a label statement would occupy more than 70 percent of the area specified by subparagraph (A), such text may appear in a smaller type size, so long as at least 60 percent of such warning area is occupied by the label statement. ‘‘(3) The label statements required by paragraph (1) shall be introduced by each tobacco product manufacturer, packager, importer, distributor, or retailer of smokeless tobacco products concurrently into the distribution chain of such products. ‘‘(4) The provisions of this subsection do not apply to a tobacco product manufacturer or distributor of any smokeless tobacco product that does

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145 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 not manufacture, package, or import smokeless tobacco products for sale or distribution within the United States. ‘‘(5) A retailer of smokeless tobacco products shall not be in violation of this subsection for packaging that is supplied to the retailer by a tobacco products manufacturer, importer, or distributor and that is not altered by the retailer unless the retailer offers for sale, sells, or distributes a smokeless tobacco product that is not labeled in accordance with this subsection. ‘‘(b) REQUIRED LABELS.— ‘‘(1) It shall be unlawful for any tobacco product manufacturer, packager, importer, distributor, or retailer of smokeless tobacco products to advertise or cause to be advertised within the United States any smokeless tobacco product unless its advertising bears, in accordance with the requirements of this section, one of the labels specified in subsection (a). ‘‘(2) Each label statement required by subsection (a) in smokeless tobacco advertising shall comply with the standards set forth in this paragraph. For press and poster advertisements, each such statement and (where applicable) any required

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146 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 statement relating to tar, nicotine, or other constituent yield shall— ‘‘(A) comprise at least 20 percent of the area of the advertisement, and the warning area shall be delineated by a dividing line of contrasting color from the advertisement; and ‘‘(B) the word ‘WARNING’ shall appear in capital letters and each label statement shall appear in conspicuous and legible type. The text of the label statement shall be black on a white background, or white on a black background, in an alternating fashion under the plan submitted under paragraph (3). ‘‘(3)(A) The label statements specified in subsection (a)(1) shall be randomly displayed in each 12-month period, in as equal a number of times as is possible on each brand of the product and be randomly distributed in all areas of the United States in which the product is marketed in accordance with a plan submitted by the tobacco product manufacturer, importer, distributor, or retailer and approved by the Secretary. ‘‘(B) The label statements specified in subsection (a)(1) shall be rotated quarterly in alternating sequence in advertisements for each brand of

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147 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 smokeless tobacco product in accordance with a plan submitted by the tobacco product manufacturer, importer, distributor, or retailer to, and approved by, the Secretary. ‘‘(C) The Secretary shall review each plan submitted under subparagraph (B) and approve it if the plan— ‘‘(i) will provide for the equal distribution and display on packaging and the rotation required in advertising under this subsection; and ‘‘(ii) assures that all of the labels required under this section will be displayed by the tobacco product manufacturer, importer, distributor, or retailer at the same time. ‘‘(D) This paragraph applies to a retailer only if that retailer is responsible for or directs the label statements under this section, unless the retailer displays in a location open to the public, an advertisement that is not labeled in accordance with the requirements of this subsection. ‘‘(c) TELEVISION
AND

RADIO ADVERTISING.—It is

22 unlawful to advertise smokeless tobacco on any medium 23 of electronic communications subject to the jurisdiction of 24 the Federal Communications Commission.’’.

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SEC. 205. AUTHORITY TO REVISE SMOKELESS TOBACCO PRODUCT WARNING LABEL STATEMENTS.

Section 3 of the Comprehensive Smokeless Tobacco

4 Health Education Act of 1986 (15 U.S.C. 4402), as 5 amended by section 203, is further amended by adding 6 at the end the following: 7 ‘‘(d) AUTHORITY TO REVISE WARNING LABEL

8 STATEMENTS.—The Secretary may, by a rulemaking con9 ducted under section 553 of title 5, United States Code, 10 adjust the format, type size, and text of any of the label 11 requirements, require color graphics to accompany the 12 text, increase the required label area from 30 percent up 13 to 50 percent of the front and rear panels of the package, 14 or establish the format, type size, and text of any other 15 disclosures required under the Federal Food, Drug, and 16 Cosmetic Act (21 U.S.C. 301 et seq.), if the Secretary 17 finds that such a change would promote greater public un18 derstanding of the risks associated with the use of smoke19 less tobacco products.’’. 20 21 22
SEC. 206. TAR, NICOTINE, AND OTHER SMOKE CON-

STITUENT DISCLOSURE TO THE PUBLIC.

Section 4(a) of the Federal Cigarette Labeling and

23 Advertising Act (15 U.S.C. 1333 (a)), as amended by sec24 tion 201, is further amended by adding at the end the 25 following:

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149 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 ‘‘(4)(A) The Secretary shall, by a rulemaking conducted under section 553 of title 5, United States Code, determine (in the Secretary’s sole discretion) whether cigarette and other tobacco product manufacturers shall be required to include in the area of each cigarette advertisement specified by subsection (b) of this section, or on the package label, or both, the tar and nicotine yields of the advertised or packaged brand. Any such disclosure shall be in accordance with the methodology established under such regulations, shall conform to the type size requirements of subsection (b) of this section, and shall appear within the area specified in subsection (b) of this section. ‘‘(B) Any differences between the requirements established by the Secretary under subparagraph (A) and tar and nicotine yield reporting requirements established by the Federal Trade Commission shall be resolved by a memorandum of understanding between the Secretary and the Federal Trade Commission. ‘‘(C) In addition to the disclosures required by subparagraph (A) of this paragraph, the Secretary may, under a rulemaking conducted under section 553 of title 5, United States Code, prescribe disclo-

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150 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 sure requirements regarding the level of any cigarette or other tobacco product constituent including any smoke constituent. Any such disclosure may be required if the Secretary determines that disclosure would be of benefit to the public health, or otherwise would increase consumer awareness of the health consequences of the use of tobacco products, except that no such prescribed disclosure shall be required on the face of any cigarette package or advertisement. Nothing in this section shall prohibit the Secretary from requiring such prescribed disclosure through a cigarette or other tobacco product package or advertisement insert, or by any other means under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). ‘‘(D) This paragraph applies to a retailer only if that retailer is responsible for or directs the label statements required under this section, except that this paragraph shall not relieve a retailer of liability if the retailer sells or distributes tobacco products that are not labeled in accordance with the requirements of this subsection.’’.

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TITLE III—PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS
SEC. 301. LABELING, RECORDKEEPING, RECORDS INSPECTION.

Chapter IX of the Federal Food, Drug, and Cosmetic

7 Act, as added by section 101, is further amended by add8 ing at the end the following: 9 10 11
‘‘SEC. 921. LABELING, RECORDKEEPING, RECORDS INSPECTION.

‘‘(a) ORIGIN LABELING.—The label, packaging, and

12 shipping containers of tobacco products for introduction 13 or delivery for introduction into interstate commerce shall 14 bear the statement ‘sale only allowed in the United 15 States.’ 16 17 18 19 20 21 22 23 24 25
FOR

‘‘(b) REGULATIONS CONCERNING RECORDKEEPING TRACKING AND TRACING.— ‘‘(1) IN
GENERAL.—Not

later than 9 months

after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, the Secretary shall promulgate regulations regarding the establishment and maintenance of records by any person who manufactures, processes, transports, distributes, receives, packages, holds, exports, or imports tobacco products.
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152 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 ‘‘(2) INSPECTION.—In promulgating the regulations described in paragraph (1), the Secretary shall consider which records are needed for inspection to monitor the movement of tobacco products from the point of manufacture through distribution to retail outlets to assist in investigating potential illicit trade, smuggling or counterfeiting of tobacco products. ‘‘(3) CODES.—The Secretary may require codes on the labels of tobacco products or other designs or devices for the purpose of tracking or tracing the tobacco product through the distribution system. ‘‘(4) SIZE
OF BUSINESS.—The

Secretary shall

take into account the size of a business in promulgating regulations under this section. ‘‘(5) RECORDKEEPING
BY RETAILERS.—The

Secretary shall not require any retailer to maintain records relating to individual purchasers of tobacco products for personal consumption. ‘‘(c) RECORDS INSPECTION.—If the Secretary has a

21 reasonable belief that a tobacco product is part of an illicit 22 trade or smuggling or is a counterfeit product, each person 23 who manufactures, processes, transports, distributes, re24 ceives, holds, packages, exports, or imports tobacco prod25 ucts shall, at the request of an officer or employee duly

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153 1 designated by the Secretary, permit such officer or em2 ployee, at reasonable times and within reasonable limits 3 and in a reasonable manner, upon the presentation of ap4 propriate credentials and a written notice to such person, 5 to have access to and copy all records (including financial 6 records) relating to such article that are needed to assist 7 the Secretary in investigating potential illicit trade, smug8 gling or counterfeiting of tobacco products. 9 ‘‘(d) KNOWLEDGE
OF

ILLEGAL TRANSACTION.—If

10 the manufacturer or distributor of a tobacco product has 11 knowledge which reasonably supports the conclusion that 12 a tobacco product manufactured or distributed by such 13 manufacturer or distributor that has left the control of 14 such person may be or has been— 15 16 17 18 19 20 ‘‘(A) imported, exported, distributed or offered for sale in interstate commerce by a person without paying duties or taxes required by law; or ‘‘(B) imported, exported, distributed or diverted for possible illicit marketing,

21 the manufacturer or distributor shall promptly notify the 22 Attorney General of such knowledge. 23 24 25 ‘‘(1) KNOWLEDGE
DEFINED.—For

purposes of

this subsection, the term ‘knowledge’ as applied to a manufacturer or distributor means—

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154 1 2 3 4 5 6 7 8 ‘‘(A) the actual knowledge that the manufacturer or distributor had; or ‘‘(B) the knowledge which a reasonable person would have had under like circumstances or which would have been obtained upon the exercise of due care.’’
SEC. 302. STUDY AND REPORT.

(a) STUDY.—The Comptroller General of the United

9 States shall conduct a study of cross-border trade in to10 bacco products to— 11 12 13 14 15 16 17 18 19 20 21 22 (1) collect data on cross-border trade in tobacco products, including illicit trade and trade of counterfeit tobacco products and make recommendations on the monitoring of such trade; (2) collect data on cross-border advertising (any advertising intended to be broadcast, transmitted, or distributed from the United States to another country) of tobacco products and make recommendations on how to prevent or eliminate, and what technologies could help facilitate the elimination of, cross-border advertising. (b) REPORT.—Not later than 18 months after the

23 date of enactment of this Act, the Comptroller General 24 of the United States shall submit to the Committee on 25 Health, Education, Labor, and Pensions of the Senate and

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155 1 the Committee on Energy and Commerce of the House 2 of Representatives a report on the study described in sub3 section (a).

Æ

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DOCUMENT INFO
Description: 108th Congress H.R. 4433 (ih): To protect the public health by providing the Food and Drug Administration with certain authority to regulate tobacco products. [Introduced in House] 2003-2004